Inquiry™ 1000 and 1100 Series Electrophysiology Catheter
Caution:
• United States law restricts this device to sale by or on order of a physician.
• Read directions prior to use.
Description:
Inquiry™ fixed curve and steerable electrophysiology catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle at the proximal end of the catheter.
Indications For Use:
The Inquiry™ fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
Contraindications:
The Inquiry catheter is contraindicated for:
• Via the transseptal approach in patients with left atrial thrombus or myxoma, or interatrial baffle or patch
• Via the retrograde transaortic approach in patients with aortic valve replacement
• Transcatheter ablation
Warnings:
• This device should be used by or under the supervision of physicians thoroughly trained in the techniques of transvenous electrophysiology studies.
• Cardiac catheterization procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic effects, to both patients and laboratory staff due to the x-ray beam intensity and duration of the fluoroscopic imaging. Careful consideration must therefore be given for the use of this catheter in pregnant women.
• Vascular perforation is an inherent risk of any electrode placement. Do not force the catheter through the vessel.
• Catheter entrapment within the heart or blood vessels is a possible complication of electrophysiology procedures.
• This device is intended for one time use only. Do not reprocess or reuse. Reuse can cause patient injury and/or the communication of infectious disease(s) from one patient to another.
Precautions:
• Personnel handling the electrophysiology catheter should wear gloves.
• To maintain optimal patient safety and electrode catheter integrity, do not wipe this catheter with alcohol.
• Excessive bending or kinking of the catheter may cause damage to the catheter. Manual prebending of the distal curve can damage the steering mechanism and may cause patient injury.
• Standard grounding procedures should be followed if electrosurgical instruments are used.
• Do not immerse the proximal handle or cable connector in fluids; electrical performance could be affected.
• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
