CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Indications: The FlexAbility™ Ablation Catheter, Sensor Enabled™ is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of typical atrial flutter.
Contraindications: In patients with active systemic infection. In patients with intracardiac mural thrombus or those who have had a ventriculotomy or atriotomy within the preceding four weeks.
Warnings: Catheter ablation procedures present the potential for significant x-ray exposure. The long-term risk of protracted fluoroscopy has not been established. Careful consideration must be given for the use of the device in prepubescent children and pregnant women. The long terms risks of RF ablation lesions have not been established. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. Always verify the tubing and catheter have been properly cleared of air prior to inserting the catheter into the vasculature since entrapped air can cause potential injury or fatality.
Precautions: If the irrigation pump alarm sounds, terminate RF delivery. If impedance rises suddenly that does not exceed the preset limit, power delivery should be manually discontinued. Always maintain constant irrigation to prevent coagulation within and around electrodes. Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Care should be taken when ablation near electrically vulnerable, thin-walled or other arterial structures. If irrigation is interrupted, immediately inspect and reflush the catheter outside of the patient. Reestablish irrigation flow prior to placing catheter in the body. Do not attempt ablation without using an irrigation pump.
Potential adverse events: Potential adverse events include, but are not limited to, cardiovascular and anesthesia-related complications, including inadvertent AV block. Please refer to the Instructions for Use of a complete list.