The RF Marinr™ 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.
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.
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 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.
Storage conditions – Optimal storage conditions for the catheter are these: 15° C to 30° C (59° F to 86° F); no air pressure limitations.
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.
Sterilization – Medtronic has sterilized the package contents using irradiation before shipment. This device is for single use only and is not intended to be resterilized.
Power limit – Limit power output to no more than 50 W on the RF power generator.
Handling RF catheters during therapy – Do not touch the ablation electrode of the RF catheter and the dispersive electrode at the same time, especially while operating the Medtronic RF power generator. Operator injury may occur.
Implanted devices – Implanted devices, such as pacemakers and implantable cardioverter-defibrillators (ICDs), may be adversely affected by RF energy. Be aware of the following when using RF energy near implanted devices.
Magnetic resonance imaging (MRI) – Catheter materials are not compatible with magnetic resonance imaging (MRI).
DC energy – Do not deliver DC energy through the RF power generator or the catheter. Neither the RF power generator nor the catheter was designed to deliver DC energy. No testing has been performed on the RF power generator or the catheter regarding the delivery of DC energy.
Contact with other electrodes – Verify that the 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.
Sudden rise in impedance – Discontinue energy delivery if a sudden rise in impedance is observed during the ablation procedure. Examine the catheter ablation electrodes and remove coagulum if present.
Catheter performance – Bench testing of Medtronic RF catheters demonstrated that they could withstand 25 RF energy deliveries without any reduction in performance.
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.
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. Please take the following precautions:
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 60601-1 Type CF equipment) or patient injury or death may occur. Leakage current from any connected device to the patient must not exceed 10 microamps (µA) 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.
Hazards related to the 5 FR RF Marinr™ catheter
Potential adverse events or potential complications
Potential complications/adverse events from cardiac catheterization and ablation include, but are not limited to, the following: Pulmonary embolism; Myocardial infarction; Cerebrovascular accident; Cardiac damage; Coronary sinus perforation; Cardiac tamponade; Perforation of the vasculature; Death; Unintended AV or bundle branch block requiring new pacemaker; Bacterial endocarditis; Ventricular fibrillation; Coronary artery spasm; Thrombus/embolic event; Bowel obstruction; Brachial plexus injury; Pneumonia; Inferior vena cava clot; Deep vein thrombosis; Pericardial effusion; Pericarditis; Pleural effusion; Respiratory depression; Atrial lead dislodgement; Infected IV site; Hypotension; Bradycardia; Vasovagal reaction; Thrombophlebitis; Temperature elevation; Puncture site hematoma; Phlebothrombosis; High CPK; Valvular insufficiency; Femoral artery laceration; Thromboembolism; Nerve or blood vessel injury; Transient ischemic attack; Infection.
Refer to the device technical 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 the Medtronic website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a Physician
MAJ_83945
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