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
EP-XT, DYNAMIC TIP and DYNAMIC XT Unidirectional Steerable Diagnostic Catheters are intended for temporary Intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
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.
- This device should be used only by physicians thoroughly trained in the techniques of intracardiac electrophysiology studies and temporary pacing.
- 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.
- 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.
- Catheter advancement should be done under fluoroscopic guidance.
- The safety and effectiveness of this device as an ablation catheter have not been established. Therefore, such use is considered investigational.
- Use only sterile saline or water to wipe this catheter.
- Avoid submerging the catheter handle in any solution.
- For catheters equipped with a cable connector, use with the appropriate Boston Scientific cable.
- Excessive bending, torquing or kinking of the electrode catheter may cause damage to the catheter, including damage to the internal wires.