072402

Marinr™ MC diagnostic catheter with handle

Indications, Safety, and WarningsIndications for useThe 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.ContraindicationsContraindications for the Marinr steerable intracardiac electrode catheter include the following conditions:

Active sepsis

Known sensitivity to heparin

Blood clotting abnormalities

Venous filtering device

Use of catheter in an obstructed or damaged vessel

The catheter is not recommended for use in patients who cannot undergo standard anticoagulation protocol for a left-sided cardiac procedure, or who have had a recent coagulopathy or embolic event.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

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.

U.S. law does not permit the use of this catheter for intracardiac ablation. Do not use for direct current (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 the Medtronic website at www.medtronic.com.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.MAJ_83945

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