Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
The Therapy Cool Path Duo and Safire BLU Duo Irrigated Ablation Catheters are intended for use with a compatible irrigation pump and the 1500T9-CP RF Generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical Atrial Flutter. The Therapy Cool Path and Safire BLU Irrigated Ablation Catheters are intended for use with a compatible external infusion pump and the 1500T9-CP RF Generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical Atrial Flutter.
In patients with active systemic infection. Via the retrograde transaortic approach in patients with aortic valve replacement. Via the transseptal approach in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. In patients with intracardiac mural thrombus, ventriculotomy or atriotomy within the preceding four weeks.
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 term risks of RF ablation lesions have not been established. Patients undergoing AV nodal modification or ablation of septal accessory pathways are at risk for inadvertent AV block. 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 can cause potential injury or fatality.
Appropriate DIP pads should be used to minimize skin burns. If the irrigation pump alarm sounds, terminate RF delivery. If impedance rises suddenly that does not exceed the preset limit, power delivery MUST 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 ablating 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 complete heart block requiring pacemaker. Please refer to the Instructions for Use for a complete list.
Last Updated: January 02, 2019
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