Indications, Safety, and Warnings Cardiac Ablation Products for Non-AF Arrhythmias

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Radiofrequency (RF) Ablation Catheters

  • RF Marinr™ Multi-Curve (MC) Steerable Catheter
  • 5Fr RF Marinr™ Steerable Catheter
  • RF Contactr Dual-Curve Catheters
  • RF Enhancr Single-Curve Catheters
  • RF Conductr™ Multi-Curve (MC) Bi-Directional Catheters

INDICATIONS

RF catheters are indicated for use with the Medtronic RF 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/PRECAUTIONS

Do not attempt to operate the Medtronic ablation system or connect the ablation catheter to a Medtronic RF generator prior to completely reading and understanding the Medtronic ablation system technical manual and the ablation catheter Instructions for Use. Use the catheter with only a Medtronic RF generator, accessories, and cables. The safety and use with other RF generators or accessories has not been tested. Use only isolated amplifiers, pacing equipment, and ECG equipment or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 micro Amps. 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. Cardiac ablation procedures should be performed only in a fully equipped electrophysiology laboratory.

POTENTIAL COMPLICATIONS

Potential complications include, but are not limited to, pulmonary embolism; myocardial infarction; cerebrovascular accident; cardiac damage, perforation, and tamponade; perforation of the vasculature; partial or complete AV block; and death. 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. Catheters with distal pair electrode spacing greater than two 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. Implanted devices such as pacemakers and implantable cardioverter-defibrillators (ICDs) may be adversely affected by RF energy. Catheter materials are not compatible with magnetic resonance imaging (MRI).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Soloist Quadrapolar Fixed-Curve Catheters

Intended Use

The Medtronic 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).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Stablemapr SM Duodecapolar Steerable Catheter

INDICATIONS FOR USE

The Medtronic StableMapr 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 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).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Torqr Catheters

  • Torqr 5 Fr/Torqr 6 Fr Quadripolar Fixed-Curve Catheters
  • Torqr CS Fixed-Curve Decapolar Catheter

Intended Use

The Medtronic 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).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Marinr Catheters

  • Marinr CS Steerable Decapolar Catheter
  • Marinr MC and MCXL Steerable Catheters
  • Marinr SC Steerable Quadrapolar Catheter

INDICATIONS FOR USE

The Medtronic 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/PRECAUTIONS

  • 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 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.
  • 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).

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Brockenbrough Curved Needles

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.

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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Mullins Transseptal Introducer Sheath

The Medtronic Transseptal Catheter Introducer Sheaths are available in two designs:

Mullins Transseptal Catheters Product Description

Mullins Transseptal Catheter Introducer Set The Mullins transseptal catheter introducer set consists of a long radiopaque sheath and dilator. The distal section is curved to accommodate the curved Brockenbrough™ needle and to enable positioning against the atrial septum

Medtronic Transseptal Catheters Product Description

Medtronic Transseptal Catheter Introducer Set is the same as the Mullins Transseptal Catheter Introducer Set except that the Medtronic transseptal introducer sheath contains a gasket seal assembly within the hub to minimize blood loss during catheter introduction or exchange, and a sideport for fluid infusion, blood sampling, or pressure monitoring.  In addition, the sideport has a three-way stopcock attached.  

Contraindications

The introducer sets are contraindicated for use under these conditions:

  • Known or suspected left atrial myxoma
  • Previous systemic embolization from left side of the heart
  • Previous intra-atrial septal pouch

Warnings

  • Do not advance the dilator or sheath through the interatrial septum without first observing an acceptable left atrial pressure tracing. Advancing the dilator or sheath too quickly could cause placement in an undesired location or subsequent bleeding.
  • Use repeated biplane fluoroscopy of the tip during any positioning to prevent advancing the device into an undesired location and the subsequent bleeding that might occur.
  • Maintain continuous pressure monitoring and repeated anterior-posterior and lateral visualization under fluoroscopy throughout the procedure.
  • Withdraw each component slowly to help prevent a vacuum in the sheath. Do not apply suction directly to the sheath. If blood does not flow freely from the sheath, it suggests that the distal end opening is against the wall of the atrium or against a pulmonary vein. Withdraw the sheath approximately 1 finger width until flow is reestablished.
  • This device is for single use. Reuse of this device creates a potential risk of patient or user infections due to contamination. Contamination of the device may lead to injury, illness or death of the patient. Reuse, Reprocessing, resterilization may compromise the structural integrity of the device.
  • The Medtronic and Mullins transseptal catheter introducer sets are designed for use by physicians engaged in the practice of specialized invasive cardiology techniques. Use of this device should be restricted to those specialists trained to perform transseptal procedures.
  • Aspiration is recommended when withdrawing the catheter or dilator to remove any fibrin deposition that may have accumulated in or on the tip of the sheath. Aspiration helps prevent embolization of the fibrin and the subsequent ischemia that might occur.
  • Perform frequent aspirations and saline flushing of the sheath, dilator, and catheter to help minimize the potential for air emboli.
  • For Medtronic Transseptal Set Only: It is essential to aspirate all air from the infusion sideport before infusion through the side port or the introduction of a catheter. Aspiration helps prevent an air embolus and the subsequent ischemia that might occur.
  • For Medtronic Transseptal Set Only: A continuous drip under pressure is required through the sideport when the introducer is left in the vessel.

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