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Fixed Curve Diagnostic Electrode Catheter

Indications, Safety, and Warnings

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Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions

INTENDED USE/INDICATIONS FOR USE

Boston Scientific fixed curve diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

CONTRAINDICATIONS

The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.

WARNINGS

This device should be used only by physicians thoroughly trained in the techniques of intracardiac electrophysiology studies and temporary pacing. This device is for single use only. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.  Do not use excessive force to advance or withdraw the catheter when resistance is encountered. If using an open lumen catheter remove any guidewire / stylette prior to electrical stimulation.

PRECAUTIONS

Excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter, including damage to the internal wires. Use only sterile saline or water to wipe this catheter. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws.

POTENTIAL ADVERSE EVENTS

The risks of using electrophysiology catheters include those risks related to heart catheterization, such as thromboembolism, perforation, tamponade, and infection. The induction of an unintended arrhythmia is a known complication.

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