Marinr (Multi-Curve) and MCXL Series

Indications, Safety, and Warnings

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. 

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.