Indications, Contraindications, Warnings, Precautions, and adverse effects

Torqr® 6F

Intended Use
The Medtronic CardioRhythm Torqr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Contraindications
There are no known contraindications for this catheter.

Warnings

• This device is for single use only. Do not resterilize and/or reuse.
• Catheter resterilization and reuse may result in loss of proper electrical or mechanical function and could cause patient injury.
• This catheter should be used by or under the supervision of physicians thoroughly trained in electrophysiology, including the placement and use of intracardiac electrode catheters.
• Electrical recording or stimulation equipment must be “front end” isolated, or have an isolated patient cable. Current leakage from any connected electrical equipment must not exceed 10 µA for intracardiac electrodes.
• Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection.
• US LAW DOES NOT PERMIT THE USE OF THIS CATHETER FOR INTRACARDIAC ABLATION. DO NOT USE FOR DC ABLATION. PRECAUTIONS
• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Excessive bending or kinking of catheter may damage internal electrode wires and/or distal tip shaping capabilities.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).

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Torqr® 5F

Indications for use
The Medtronic CardioRhythm Torqr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Contraindications
There are no known contraindications for this catheter.

Warnings and precautions

• This device is for single use only. Do not resterilize and/or reuse. Catheter resterilization and reuse may result in loss of proper electrical or mechanical function and could cause patient injury.
• This catheter should be used by or under the supervision of physicians thoroughly trained in electrophysiology, including the placement and use of intracardiac electrode catheters.
• Electrical recording or stimulation equipment must be “front end” isolated, or have an isolated patient cable. Current leakage from any connected electrical equipment must not exceed 10 µA for intracardiac electrodes.
• Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection.
• US LAW DOES NOT PERMIT THE USE OF THIS CATHETER FOR INTRACARDIAC ABLATION. DO NOT USE FOR DC ABLATION.

Precautions

• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Excessive bending or kinking of catheter may damage internal electrode wires and/or distal tip shaping capabilities.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).

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Soloist™

Intended Use
The Medtronic CardioRhythm Soloist catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Contraindications
There are no known contraindications for this catheter.

Warnings

• This device is for single use only. Do not resterilize and/or reuse. Catheter resterilization and reuse may result in loss of proper electrical or mechanical function and could cause patient injury.
• This catheter should be used by or under the supervision of physicians thoroughly trained in electrophysiology, including the placement and use of intracardiac electrode catheters.
• Electrical recording or stimulation equipment must be "front end" isolated, or have an isolated patient cable. Current leakage from any connected electrical equipment must not exceed 10 µA for intracardiac electrodes.
• Do not use in the coronary vasculature other than in the coronary sinus.
• Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection.
• US LAW DOES NOT PERMIT THE USE OF THIS CATHETER FOR INTRACARDIAC ABLATION. DO NOT USE FOR DC ABLATION.

Precautions

• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Excessive bending or kinking of catheter may damage internal electrode wires.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).

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Stablemapr™ SM

Intended Use
The Medtronic StableMapr catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Contraindications
There are no known contraindications for these catheters. 2 English Instructions for use

Warnings

• This device is for single use only. Do not resterilize and reuse the catheter. This may result in loss of proper electrical and mechanical function.
• This catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including the placement and use of intracardiac electrode catheters.
• Electrical recording or stimulation equipment must be “front end isolated”, or have an isolated patient cable (IEC 601-1 Type CF equipment or equivalent). Current leakage from any connected electrical equipment must not exceed 10 µA for intracardiac electrodes.
• Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection and death.
• Use only connecting cables supplied by Medtronic or patient injury, operator injury, or equipment damage may occur.
• Do not allow moisture into connectors of the StableMapr catheter or connecting cables. If the connectors get wet, the system may not function correctly.
• The safety and effectiveness of this device as an ablation catheter have not been established. Therefore, such use is considered investigational.

Precautions

• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Excessive bending or kinking of catheter may damage internal electrode wires and/or distal tip shaping capabilities.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).

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RF Conductr® MC

Intended Use
The RF Conductr MC catheter is intended for use with the Atakr RF Power Generator to deliver RF energy for intracardiac ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia, for the treatment of AV nodal re-entrant tachycardia, and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.

Contraindications
The use of this device is contraindicated in patients with active systemic infection.
The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.

Warnings

• Catheter ablation procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic effects, to both patients and laboratory staff due to the x-ray beam intensity and duration of the fluoroscopic imaging. Catheter ablation should only be performed after adequate attention has been given to the potential radiation exposure associated with the procedure, and steps taken to minimize this exposure. Careful consideration must therefore be given to the use of the device in pregnant women.
• During a transaortic approach, adequate fluoroscopic visualization is necessary to avoid placement of the ablation catheter within the coronary vasculature. Catheter placement and RF power application within a coronary artery has been associated with myocardial infarction and death.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).
• Perforation of the vasculature is an inherent risk of any catheter placement. A number of serious adverse events have been documented for catheter ablation procedures including pulmonary embolism, myocardial infarction, stroke, cardiac tamponade, and death. See Adverse Events, for additional potential complications.
• Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for clinical manifestations of infarction.
• Catheters with distal pair electrode spacing greater than 2 mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block.
• Implantable pacemakers and implantable cardioverter/defibrillators (ICDs) may be adversely affected by radiofrequency (RF) current. It is important to: have temporary external sources of pacing and defibrillation available during ablation; exercise extreme caution during ablation when in close proximity to atrial or ventricular permanent leads; and, perform complete implantable device analysis for all patients after ablation.
• Implanted cardioverter/defibrillators should be deactivated during delivery of RF power.
• Patients undergoing AV node modification or septal accessory pathway ablation are at risk for complete AV block. Permanent pacing was required in 1.6% (2/128) of septal accessory pathway, 3.1% (1/32) of left posterior pathways, and 1.7% (4/238) of AV nodal modification patients who experienced inadvertent partial or complete AV block during the study. Closely monitor AV conduction during RF energy delivery. Immediately terminate energy delivery if partial or complete AV block is noted.
• The Atakr RF Power Generator is capable of delivering significant RF power. Do not touch the distal tip of the CardioRhythm RF catheter and the dispersive electrode at the same time especially while operating the Atakr RF Power Generator or operator injury may occur.
• Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 micro Amps (µA) under any circumstances.
• The CardioRhythm RF catheters are disposable and intended for single use only. Do not resterilize or reuse. This may result in loss of proper electrical and mechanical function and could cause patient injury and/or the communication of infectious diseases from one patient to another.
• Precautions
  Do not attempt to operate the Atakr Ablation System or connect the catheter to the Atakr RF Power Generator prior to completely reading and understanding the Atakr Ablation System Technical Manual and the RF Conductr MC catheter Instructions For Use.
• Cardiac ablation procedures should be performed only by appropriately trained personnel in a fully-equipped electrophysiology laboratory.
• This catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including the placement and use of intracardiac electrode catheters and experienced in performing radiofrequency catheter ablation procedures.
• The long-term risks of protracted fluoroscopy have not been established. Careful consideration must therefore be given for the use of the device in prepubescent children.
• The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown. Furthermore, the risk/benefit in asymptomatic patients has not been studied.
• The CardioRhythm RF catheters are intended for use only with the Atakr RF Power Generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only Medtronic CardioRhythm cables supplied with the Atakr Ablation System.
• Excessive bending or kinking of catheter may damage internal electrode wires and/or distal tip shaping capabilities.
• Do not allow moisture into connectors on the CardioRhythm RF catheter, Atakr RF Power Generator, or cables. If the connectors get wet, the system may not function correctly.
• The sterile packaging and catheter should be inspected prior to use. If damaged, do not use; contact your local Medtronic representative.
• Careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade. Catheter advancement should be performed under fluoroscopic guidance. Do not use excessive force to advance or withdraw the catheter when resistance is encountered.
• See Atakr Technical Manual (Section 9.10) for information concerning catheter removal following generator shutdown.
• Do not deliver DC energy through the Atakr Ablation System or the CardioRhythm RF catheter. Neither the Atakr Ablation System nor the CardioRhythm RF catheter were designed to deliver DC energy and no testing has been performed.
• Verify that RF catheter tip electrode is not in contact with electrodes of other catheters in the heart or heating of the other electrodes may occur.
• The catheter impedance display should be monitored during energy delivery. If a sudden impedance rise is observed during the ablation procedure, energy delivery should be discontinued and the catheter tip examined for coagulum, and coagulum removed if present.
• Do not begin an ablation procedure if the LOW BATTERY display is illuminated on the Atakr RF Power Generator. Replace battery.
• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Bench testing of CardioRhythm RF catheters demonstrated that they could withstand twenty-five RF energy deliveries without any reduction in performance. During the clinical trial as many as 73 energy deliveries were made with a single catheter, although the average number was about seven.

Clinical Summary
Please refer to the Atakr Ablation System Technical Manual for the Clinical Background.

Adverse Events
One or more adverse events were reported in 67 of the 683 patients (a total of 88 adverse events) during the clinical study of the Atakr Ablation System. The following adverse events are listed in descending order according to their clinical significance as determined by their severity and frequency
(< 1% unless otherwise indicated).

Other complications of catheter ablation procedures which have been reported in the literature include:

Pulmonary Embolism	Nerve or Blood	Transient Ischemic Attack
Thromboembolism	Vessel Injury	Infection

There were 18 deaths reported among the 683 patients enrolled in the study. None of the 18 deaths were judged by the investigators as definitely related to the use of the Atakr RFCA System, but two deaths were judged as possibly device related and a third as possibly procedure related.

Device related complications were reported in 30 of the 683 patients (4%) including unintentional AV block in 13 patients (1.9%), pericardial effusion in 8 patients (1.2%), and cardiac tamponade in 3 patients (0.4%).

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5mm Tip RF Conductr®

Intended use
The RF Conductr MC - 5 mm Tip catheter is intended for use with a Medtronic RF power generator to deliver RF energy for intracardiac ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia, for the treatment of AV nodal re-entrant tachycardia, and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.

Contraindications
The use of this device is contraindicated in patients with active systemic infection.
The transeptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch.
The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.

Warnings

• Catheter ablation procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic defects, to both patients and laboratory staff due to the x-ray beam intensity and duration of the fluoroscopic imaging. Catheter ablation should only be performed after adequate attention has been given to the potential radiation exposure associated with the procedure, and steps taken to minimize this exposure. Careful consideration must therefore be given to the use of the device in pregnant women.
• During a transaortic approach, adequate fluoroscopic visualization is necessary to avoid placement of the ablation catheter within the coronary vasculature. Catheter placement and RF power application within a coronary artery has been associated with myocardial infarction and death.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).
• Perforation of the vasculature is an inherent risk of any catheter placement. A number of serious adverse events have been documented for catheter ablation procedures including pulmonary embolism, myocardial infarction, stroke, cardiac tamponade, and death. See Adverse events for additional potential complications.
• Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for clinical manifestations of infarction.
• Catheters with distal pair electrode spacing greater than 2 mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block.
• Implantable pacemakers and implantable cardioverter/defibrillators (ICDs) may be adversely affected by RF current. It is important to: have temporary external sources of pacing and defibrillation available during ablation; exercise extreme caution during ablation when in close proximity to atrial or ventricular permanent leads; and perform complete implantable device analysis for all patients after ablation.
• ICDs should be deactivated during delivery of RF power.
• Patients undergoing AV node modification or septal accessory pathway ablation are at risk for complete AV block. Permanent pacing was required in 1.6% (2/128) of septal accessory pathway, 3.1% (1/32) of left posterior pathways, and 1.7% (4/238) of AV nodal modification patients who experienced inadvertent partial or complete AV block during a Medtronic clinical study. Closely monitor AV conduction during RF energy delivery. Immediately terminate energy delivery if partial or complete AV block is noted. Medtronic RF power generators are capable of delivering significant RF power. Do not touch the distal tip or the adjacent shaft electrode(s) of the RF Conductr MC - 5 mm Tip catheter and the dispersive electrode at the same time, especially while operating the
• Medtronic RF power generator, or operator injury may occur. Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 micro Amps (mA) under any circumstances.
• The RF Conductr MC - 5 mm Tip catheters are disposable and intended for single use only. Do not resterilize or reuse. This may result in loss of proper electrical and mechanical function and could cause patient injury and/or the communication of infectious diseases from one patient to another.

Precautions

• Do not attempt to operate the Medtronic ablation system or connect the RF Conductr MC - 5 mm Tip catheter to a Medtronic RF power generator prior to completely reading and understanding the
• Medtronic ablation system technical manual and the RF Conductr MC - 5 mm Tip catheter instructions for use.
• Cardiac ablation procedures should be performed only by appropriately trained personnel in a fully equipped electrophysiology laboratory.
• This catheter should only be used by or under the supervision of physicians well trained in electrophysiology, including the placement and use of intracardiac electrode catheters, and experienced in performing RF catheter ablation procedures.
• The long term risks of protracted fluoroscopy have not been established. Careful consideration must therefore be given for the use of the device in prepubescent children.
• The long term risks of lesions created by RF ablation have not been established. In particular, any long term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown. Furthermore, the risk/benefit in asymptomatic patients has not been studied.
• The RF Conductr MC - 5 mm Tip catheters are intended for use only with a Medtronic RF power generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only Medtronic cables.
• Excessive bending or kinking of the catheter may damage internal electrode wires and/or distal tip shaping capabilities.
• Do not allow moisture into the connectors on the RF Conductr MC - 5 mm Tip catheter, Medtronic RF power generator, or cables. If the connectors get wet, the system may not function correctly.
• The sterile packaging and catheter should be inspected prior to use. If damaged, do not use; contact your local Medtronic representative.
• Careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade. Catheter advancement should be performed under fluoroscopic guidance. Do not use excessive force to advance or withdraw the catheter when resistance is encountered.
• See the Medtronic ablation system technical manual for information concerning catheter removal following generator shutdown.
• 4 English Instructions for use
  Do not deliver DC energy through the Medtronic ablation system or the RF Conductr MC - 5 mm Tip catheter. Neither the Medtronic ablation system nor the RF Conductr MC - 5 mm Tip catheter were designed to deliver DC energy and no testing has been performed.
• Verify that the RF Conductr MC - 5 mm Tip catheter tip electrode is not in contact with electrodes of other catheters in the heart or heating of the other electrodes may occur during RF energy delivery.
• The catheter impedance display should be monitored during energy delivery. If a sudden impedance rise is observed during the ablation procedure, energy delivery should be discontinued, the catheter ablation electrodes examined, and coagulum removed if present.
• Do not begin an ablation procedure if the LOW BATTERY display is illuminated on the Medtronic RF power generator. Replace battery.
• To maintain optimal patient safety and catheter electrode integrity do not wipe the catheter with organic solvents, such as alcohol.
• Bench testing of Medtronic RF catheters demonstrated that they could withstand twenty-five RF energy deliveries without any reduction in performance.

Clinical summary
Please refer to the Medtronic ablation system technical manual for the clinical background.

Adverse events
One or more adverse events were reported in 67 of the 683 patients (a total of 88 adverse events) during the clinical study of the Medtronic ablation system. The following adverse events are listed in descending order according to their clinical significance as determined by their severity and frequency (<1% unless otherwise indicated). Other complications of catheter ablation procedures which have been reported in the literature include:

Other complications of catheter ablation procedures which have been reported in the literature include:

There were 18 deaths reported among the 683 patients enrolled in the study. None of the 18 deaths were judged by the investigators as definitely related to the use of the Medtronic RFCA System, but two deaths were judged as possibly device related and a third as possibly procedure related.

Device related complications were reported in 30 of the 683 patients (4%) including unintentional AV block in 13 patients (1.9%), pericardial effusion in 8 patients (1.2%), and cardiac tamponade in 3 patients (0.4%).

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RF Enhancr™

Intended Use

The RF Enhancr catheter is intended for use with the Medtronic RF power generator to deliver RF energy for intracardiac ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.

Contraindications
The use of this device is contraindicated in patients with active systemic infection.
The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.

Warnings and Precautions

General

• Related product literature – Do not attempt to operate the Medtronic ablation system or connect the ablation catheter to a Medtronic RF power generator prior to completely reading and understanding the Medtronic ablation system technical manual and the ablation catheter instructions for use.
• System compatibility – Use the catheter with only a Medtronic RF power generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only Medtronic cables.
• Expert users – The catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including the placement and use of intracardiac electrode catheters, and experienced in performing RF catheter ablation procedures.
• Necessary environment – Cardiac ablation procedures should be performed only in a fully equipped electrophysiology laboratory.

Ablation therapy hazards

• Serious adverse events – A number of serious adverse events have been documented for catheter ablation procedures, including pulmonary embolism; myocardial infarction; cerebrovascular accident; cardiac damage, perforation, and tamponade; perforation of the vasculature; and death. See the “Adverse events” section for additional potential adverse events.
• Left-sided ablation procedures – Patients undergoing left-sided ablation procedures should be closely monitored during the postablation period for clinical manifestations of infarction.
• Distal pair electrode spacing of >2 mm – Catheters with distal pair electrode spacing greater than 2 mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block.
• Catheter manipulation and placement – Provide adequate fluoroscopic visualization during catheter manipulation and placement. During a transaortic approach, avoid placement of the ablation catheter within the coronary vasculature. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. Catheter placement and RF power application within a coronary artery have been associated with myocardial infarction and death.
• X-ray and fluoroscopic exposure – Due to the x-ray beam intensity and the duration of the fluoroscopic imaging during ablation procedures, patients and laboratory staff may be subjected to acute radiation injury and increased risk for somatic and genetic effects. The long-term effects of protracted fluoroscopy have not been established.
  • Mimimize x-ray exposure.
  • Carefully consider the use of the device in pregnant women and prepubescent children.
    
    
• AV conduction – Closely monitor AV conduction during RF energy delivery in patients undergoing AV node modification or septal accessory pathway ablation. These patients may be at risk for complete atrioventricular (AV) block. Immediately terminate energy delivery if partial or complete AV block is noted.
• Leakage current – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 micro Amps (mA) under any circumstances.
• Catheter removal – See your Medtronic ablation system technical manual for information concerning catheter removal following generator shutdown.
• Long-term risk – The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown. Furthermore, the risk/benefit in asymptomatic patients has not been studied.

Catheter storage and handling

• Storage conditions – Optimal storage conditions for the catheter are these: 10-50 °C, up to 95% relative humidity, noncondensing.
• Inspecting the sterile package – Inspect the sterile packaging and catheter prior to use. If either shows damage, do not use the catheter; contact your local Medtronic representative.
• Single use only – Do not resterilize or reuse Medtronic catheters, which are disposable and intended for single use only. Reuse may result in loss of proper electrical and mechanical function and could cause patient injury and/or the communication of infectious diseases from one patient to another.

Catheter handling and care –

– Do not excessively bend or kink the catheter. Excessive bending or kinking may damage internal electrode wires and/or distal tip shaping capabilities.
– Do not allow moisture onto the connectors on the catheter, Medtronic RF power generator, or cables. If the connectors get wet, the system may not function correctly.
– Do not wipe the catheter with organic solvents, such as alcohol, to maintain optimal patient safety and catheter electrode integrity.
– Dispose of the catheter according to local environmental requirements.

Adverse Events
One or more adverse events were reported in 67 of the 683 patients (a total of 88 adverse events) during the clinical study of the Medtronic ablation system. The following adverse events are listed in descending order according to their clinical significance as determined by their severity and frequency (<1% unless otherwise indicated).

Other complications of catheter ablation procedures which have been reported in the literature include:

There were 18 deaths reported among the 683 patients enrolled in the study. None of the 18 deaths were judged by the investigators as definitely related to the use of the RFCA System, but two deaths were judged as possibly device related and a third as possibly procedure related. Device related complications were reported in 30 of the 683 patients (4%) including unintentional AV block in 13 patients (1.9%), pericardial effusion in 8 patients (1.2%), and cardiac tamponade in 3 patients (0.4%).

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RF Marinr® MC

Intended Use
The RF Marinr Conductr catheter is intended for use with the Atakr RF Power Generator to deliver RF energy for intracardiac radiofrequency ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia, for the treatment of AV nodal re-entrant tachycardia, and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.

Contraindications
The use of this device is contraindicated in patients with active systemic infection. The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.

Warnings

• Performing ablation from within the coronary sinus and its venous branches with a 5 French RF Marinr Catheter may present additional safety risks because of the increased likelihood of injurying adjacent coronary arterial structures.
• Catheter ablation procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic effects, to both patients and laboratory staff due to the x-ray beam intensity and duration of the fluoroscopic imaging. Catheter ablation should only be performed after adequate attention has been given to the potential radiation exposure associated with the procedure, and steps taken to minimize this exposure. Careful consideration must therefore be given to the use of the device in pregnant women.
• During a transaortic approach, adequate fluoroscopic visualization is necessary to avoid placement of the ablation catheter within the coronary vasculature. Catheter placement and RF power application within a coronary artery has been associated with myocardial infarction and death.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).
• Perforation of the vasculature is an inherent risk of any catheter placement. A number of serious adverse events have been documented for catheter ablation procedures including pulmonary embolism, myocardial infarction, stroke, cardiac tamponade, and death. See Adverse Events, for additional potential complications.
• Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for clinical manifestations of infarction.
• Catheters with distal pair electrode spacing greater than 2 mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block.
• Implantable pacemakers and implantable cardioverter/defibrillators (ICDs) may be adversely affected by radiofrequency (RF) current. It is important to: have temporary external sources of pacing and defibrillation available during ablation; exercise extreme caution during ablation when in close proximity to atrial or ventricular permanent leads; and, perform complete implantable device analysis for all patients after ablation.
• Implanted cardioverter/defibrillators should be deactivated during delivery of RF power.
• Patients undergoing AV node modification or septal accessory pathway ablation are at risk for complete AV block. Permanent pacing was required in 1.6% (2/128) of septal accessory pathway, 3.1% (1/32) of left posterior pathways, and 1.7% (4/238) of AV nodal modification patients who experienced inadvertent partial or complete AV block during the study. Closely monitor AV conduction during RF energy delivery. Immediately terminate energy delivery if partial or complete AV block is noted.
• The Atakr RF Power Generator is capable of delivering significant RF power. Do not touch the distal tip of the CardioRhythm RF catheter and the dispersive electrode at the same time especially while operating the Atakr RF Power Generator or operator injury may occur.
• Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment, or equivalent) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 micro Amps (µA) under any circumstances.
• The CardioRhythm RF catheters are disposable and intended for single use only. Do not resterilize or reuse. This may result in loss of proper electrical and mechanical function and could cause patient injury.

Precautions

• Due to the smaller diameter of the 5 French RF Marinr Catheter, lesion dimensions may be smaller as compared to using a 7 or 8 French ablation system at similar power outputs.
• During in vitro testing with a 5 French RF Marinr Catheter under no flow conditions, this catheter demonstrated an increased frequency of temperature shutdowns.
• Do not attempt to operate the Atakr Ablation System or connect the catheter to the Atakr RF Power Generator prior to completely reading and understanding the Atakr Ablation System Technical Manual and the RF Conductr MC catheter Instructions For Use.
• Cardiac ablation procedures should be performed only by appropriately trained personnel in a fully-equipped electrophysiology laboratory.
• This catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including the placement and use of intracardiac electrode catheters and experienced in performing radiofrequency catheter ablation procedures.
• The long-term risks of protracted fluoroscopy have not been established. Careful consideration must therefore be given for the use of the device in prepubescent children.
• The long-term risks of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown. Furthermore, the risk/benefit in asymptomatic patients has not been studied.
• The CardioRhythm RF catheters are intended for use only with the Atakr RF Power Generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only Medtronic CardioRhythm cables supplied with the Atakr Ablation System.
• Excessive bending or kinking of catheter may damage internal electrode wires and/or distal tip shaping capabilities.
• Do not allow moisture into connectors on the CardioRhythm RF catheter, Atakr RF Power Generator, or cables. If the connectors get wet, the system may not function correctly.
• The sterile packaging and catheter should be inspected prior to use. If damaged, do not use; contact your local Medtronic representative.
• Careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade. Catheter advancement should be performed under fluoroscopic guidance. Do not use excessive force to advance or withdraw the catheter when resistance is encountered.
• See Atakr Technical Manual (Section 9.10) for information concerning catheter removal following generator shutdown.
• Do not deliver DC energy through the Atakr Ablation System or the CardioRhythm RF catheter. Neither the Atakr Ablation System nor the CardioRhythm RF catheter were designed to deliver DC energy and no testing has been performed.
• Verify that RF catheter tip electrode is not in contact with electrodes of other catheters in the heart or heating of the other electrodes may occur.
• The catheter impedance display should be monitored during energy delivery. If a sudden impedance rise is observed during the ablation procedure, energy delivery should be discontinued and the catheter tip examined for coagulum, and coagulum removed if present.
• Do not begin an ablation procedure if the LOW BATTERY display is illuminated on the Atakr RF Power Generator. Replace battery.
• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Bench testing of CardioRhythm RF catheters demonstrated that they could withstand twenty-five RF energy deliveries without any reduction in performance. During the clinical trial as many as 73 energy deliveries were made with a single catheter, although the average number was about seven.

Clinical Summary
Please refer to the Atakr Ablation System Technical Manual for the Clinical Background.

Adverse Events
One or more adverse events were reported in 67 of the 683 patients (a total of 88 adverse events) during the clinical study of the Atakr Ablation System. The following adverse events are listed in descending order according to their clinical significance as determined by their severity and frequency (< 1% unless otherwise indicated).

Other complications of catheter ablation procedures which have been reported in the literature include:

There were 18 deaths reported among the 683 patients enrolled in the study. None of the 18 deaths were judged by the investigators as definitely related to the use of the Atakr RFCA System, but two deaths were judged as possibly device related and a third as possibly procedure related.

Device related complications were reported in 30 of the 683 patients (4%) including unintentional AV block in 13 patients (1.9%), pericardial effusion in 8 patients (1.2%), and cardiac tamponade in 3 patients (0.4%).

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7F Marinr ®

Indications for use
The Medtronic CardioRhythm Marinr Catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Contraindications
There are no known contraindications for these catheters.

Warnings

• This device is for single use only. Do not resterilize and reuse the catheter. This may result in loss of proper electrical and mechanical function.
• This catheter should be used only by or under the supervision of physicians well trained in electrophysiology, including the placement and use of intracardiac electrode catheters.
• Electrical recording or stimulation equipment must be “front end isolated”, or have an isolated patient cable. Current leakage from any connected electrical equipment must not exceed 10 µA for intracardiac electrodes.
• Perforation of the vasculature is an inherent risk of any catheter placement. Additional potential complications are those attending any intracardiac catheterization procedure including, but not limited to: cardiac tamponade, thromboembolic episodes, hematoma, pneumothorax, local or systemic infection and death.
• Use only connecting cables supplied by Medtronic CardioRhythm or patient injury, operator injury, or equipment damage may occur.
• Do not allow moisture into connectors of the Marinr Catheter or connecting cables. If the connectors get wet, the system may not function correctly.
• US LAW DOES NOT PERMIT THE USE OF THIS CATHETER FOR INTRACARDIAC ABLATION. DO NOT USE FOR DC ABLATION. Precautions
• To maintain optimal patient safety and catheter electrode integrity do not wipe this catheter with organic solvents, such as alcohol.
• Excessive bending or kinking of catheter may damage internal electrode wires and/or distal tip shaping capabilities.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).

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Localisa®

Indications for Use
The Medtronic Localisa® Intracardiac Navigation System is intended for real-time display of electrode positions in the heart in relation to points taken and stored of previous electrode positions. These positions can be displayed simultaneously to provide a simple chamber geometry map of the heart.

The Localisa® Intracardiac Navigation System is indicated for any procedure in which electrodes need to be navigated and/or located within the heart. The Localisa® Intracardiac Navigation System, when used with data from other devices such as an RF power generator or an EP recording system, can generate ablation data maps, cardiac electrical activation maps, cardiac electrical propagation maps, or cardiac electrical potential maps.

General Cautions and Warnings
The CPU and monitor (non-medical equipment) should not be connected directly to a wall outlet. Connecting this equipment directly to a wall outlet may result in electrical safety hazards.

Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC 950 for data processing equipment and IEC 601-1-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 601-1-1. Any person who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 601-1-1. If in doubt, consult the technical service department or your local representative.

Do not disconnect the LCD power or video connections and simultaneously touch the patient.

Do not use the Localisa System in an anesthetically flammable environment.

The Localisa System has been successfully tested against the requirements of IEC 60601-1, but the possibility remains that RF interface could hamper system operation or that RF interference from the Localisa System could hamper the operation of other nearby electrical devices. If you suspect either of these conditions, try moving the conflicting equipment farther apart, separating the equipment with an RF barrier, or discontinue the use of the Localisa System.

Cautions
The Localisa System should be used only as an adjunct for intracardiac navigation. The system is not a replacement for the physician's knowledge, expertise, or judgment.

The Localisa System should be used only by qualified medical professionals who have been thoroughly trained and are experienced in its use.

The Localisa System is designed for use with only the Medtronic Atakr II RF Power Generator. No other RF power generator should be used.

Skin electrodes used to generate the Localisa Coordinate system Voltage Gradient must be placed orthogonally, mutually perpendicular, across the patient's body, targeting the heart as the centroid of the orthogonal system field.

The Localisa System is designed for use with the Medtronic 6416 Temporary Pacing Lead as the intracardiac reference for voltage measurements. The lead must be properly fixated into the wall of the heart chamber in which the procedure will be performed.

If an ablation is performed, there is a possibility that positional information may be invalid during the ablation and up to 30 seconds after the end of the ablation. If the Atakr II RF power Generator is connected to the Localisa Workstation via an RS232 serial link, the System Software will prompt the operator that an ablation is in progress. The System will not allow collections of data points for 30 seconds after an ablation.

The Power Supply Enclosure Unit weighs approximately 95 pounds (43kg). Medtronic recommends that two people lift and place the unit. Use both hands and lift the unit from the bottom.

The Localisa System components contain no user-repairable parts. For repair or replacement of any part of the system, contact technical support.

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Brockenbrough™ Needle

The Medtronic Brockenbrough curved needle is made up of an outer cannula and an inner stylet. The outer cannula is made of flexible thin-walled tubing. The inner stylet is solid, much stiffer and closely fitting, whose sharpened end protrudes 2-3 mm beyond the tip of the cannula.

Indications for use
The Brockenbrough curved needle is used in conjunction with transseptal catheters to puncture the atrial septum to allow conducting a left heart catheterization procedure through the right atrium. The Brockenbrough curved needle is intended for single use only.

Contraindications
The use of the Brockenbrough curved needle is contraindicated in patients with the following conditions.

• distorted anatomy due to congenital heart disease
• significant chest or spine deformity
• the inability to lie flat
• ongoing anticoagulation
• marked atrial enlargement
• left atrial thrombus or tumor
• dilated aortic root
• previous patch repair of the interatrial septum

Warnings and precautions

• The Brockenbrough curved needle is designed for use by physicians engaged in the practice of specialized invasive cardiology techniques. Use of this needle should be restricted to those specialists trained to perform transseptal procedures to minimize the complications associated with this procedure.
• The Brockenbrough curved needle must be sharp to minimize the risk of puncturing the left atrial wall just after crossing the septum.
• Use continuous pressure monitoring and repeated biplane fluoroscopy of the tip during any positioning, to minimize the risk of advancing the Brockenbrough curved needle into an undesired location and the subsequent bleeding that might occur.
• Extreme caution should be used in patients with a small left atrium, to avoid puncture of the left atrial wall.
• Never advance the Brockenbrough curved needle until the catheter is correctly positioned on the atrial septum to minimize the risk of advancing the needle into an undesired location.
• Never advance a dilator, sheath or catheter until the Brockenbrough curved needle has clearly entered the left atrial cavity, as confirmed by a distinct left atrial pressure record and the tip of the needle is in the left atrium on fluoroscopy.
• If a dilator, sheath or catheter are inadvertently advanced into the pericardial space, do not remove them until the patient is in surgery.
• Do not reuse the Brockenbrough curved needle. The Brockenbrough curved needle must be discarded after one procedure. Its structural integrity and/or function can be impaired through reuse or cleaning. All parts are extremely difficult to clean after being exposed to biological materials, and adverse patient reactions can result from reuse.
• The Brockenbrough curved needle has been gamma sterilized prior to shipment. Carefully inspect the package before opening. Damaged packages should be returned to Medtronic. The Brockenbrough curved needle cannot be resterilized.
• Do not use the product after its expiration date.
• At no time should the introducer or guide wire be advanced or withdrawn when resistance is met without first determining the cause by fluoroscopy and taking remedial action.
• Ensure that the catheter is appropriate for the Brockenbrough curved needle being used.
• After use, the Brockenbrough curved needle may be a potential biohazard. Handle and dispose of it in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

Adverse events
In addition to the complications associated with any cardiac catheterization, the following can occur during a transseptal catheterization:

• puncture of the atrial free wall
• puncture of the aorta
• puncture of the inferior vena cava
• puncture of the coronary sinus
• tamponade
• arterial embolism from thrombus at the puncture site
• atrial arrhythmias
• residual atrial septal defects

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RF Contactr™

Intended use
The RF Contactr catheter is intended for use with a Medtronic RF power generator to deliver RF energy for intracardiac radiofrequency ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.

Contraindications
The use of this device is contraindicated in patients with active systemic infection. The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.

Warnings and precautions

General

Related product literature Do not attempt to operate the Medtronic ablation system or connect the ablation catheter to a Medtronic RF power generator prior to completely reading and understanding the Medtronic ablation system technical manual and the ablation catheter technical manual.

System compatibility Use the catheter with only a Medtronic RF power generator and accessories. The safety and use with other RF power generators or accessories has not been tested. Use only Medtronic cables.

Users The catheter should be used only by or under the supervision of physicians trained in electrophysiology. This training includes the placement and use of intracardiac electrode catheters and experience in performing RF catheter ablation procedures.

Necessary environment Cardiac ablation procedures should be performed only in a fully equipped electrophysiology laboratory.

Ablation therapy hazards Left-sided ablation procedures Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for clinical manifestations of infarction.

Distal pair electrode spacing of >2 mm Catheters with distal pair electrode spacing greater than 2 mm should not be used in the ablation of septal accessory pathways or in the treatment of AV nodal re-entrant tachycardia because of the potential for creating inadvertent complete AV block.

Catheter manipulation and placement Provide adequate fluoroscopic visualization during catheter manipulation and placement. During a transaortic approach, avoid placement of the ablation catheter within the coronary vasculature. Do not use excessive force to advance or withdraw the catheter when resistance is encountered. Catheter placement and RF power application within a coronary artery have been associated with myocardial infarction and death.

X-ray and fluoroscopic exposure Due to the x-ray beam intensity and the duration of the fluoroscopic imaging during ablation procedures, patients and laboratory staff may be subjected to acute radiation injury and increased risk for somatic and genetic effects. Because the long-term effects of protracted fluoroscopy have not yet been established, please take the following precautions.

• Minimize x-ray exposure.
• Carefully consider the use of x-ray and fluorocopy in pregnant women and prepubescent children.

AV conduction Closely monitor AV conduction during RF energy delivery in patients undergoing AV node modification or septal accessory pathway ablation. These patients may be at risk for complete atrioventricular (AV) block. Immediately terminate energy delivery if partial or complete AV block is noted.

Leakage current Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 601-1 Type CF equipment) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 “A under any circumstances.

Catheter removal Before removing the catheter, ensure that the catheter tip is not curved or deflected. Patient injury may occur.

Long-term risk of lesions The long-term risk of lesions created by RF ablation have not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown. Furthermore, the risk/benefit in asymptomatic patients has not been studied.

Catheter storage and handling Storage conditions Optimal storage conditions for the catheter are: 10-50 ˇC (50-122 ˇF), up to 95% relative humidity, noncondensing. Inspecting the sterile package Inspect the sterile package and catheter prior to use. If either shows damage, do not use the catheter and contact your local Medtronic representative.

Single use only Do not resterilize or reuse Medtronic catheters. Medtronic catheters are disposable and intended for single use only. Reuse may result in loss of proper electrical and mechanical function and could cause patient injury and/or the communication of infectious diseases from one patient to another.

Catheter handling and care Follow the precautions below when handling the catheter.

• Do not excessively bend or kink the catheter. Excessive bending or kinking may damage internal electrode wires and/or distal tip shaping capabilities.
• Do not allow moisture onto the connectors on the catheter, Medtronic RF power generator, or cables. If the connectors get wet, the system may not function correctly.
• Do not wipe the catheter with organic solvents (i.e. alcohol). Using organic solvents on the catheter degrades the catheter's electrode integrity, and thereby diminishes patient safety.
• Dispose of the catheter according to local environmental requirements.

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Atakr^® II

Features:

• 60 Watt output
• Closed-loop temperature control
• Operates in power or temperature mode
• LEM feature provides tip to tissue contact
• Adjustable impedance parameters
• Adjustable power and temperature limits for safety
• Remote control electronic foot pedal
• Line powered
  

The System comes equipped with the following:

1 – 60 Watt RF Generator
1 – Electronic foot pedal
1 – Atakr to RF catheter cable
1 – Dispersive electrode cable
1 – Atakr to EGM cable