TactiCath

TactiCath™ Ablation Catheter, Sensor Enabled™

Rx Only. Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.

United States: Required Safety Information

Indications: The TactiCath Ablation Catheter, Sensor Enabled are indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic, paroxysmal, and persistent atrial fibrillation, when used in conjunction with a compatible RF generator and three-dimensional mapping system. Contraindications: Do not use for any of the following conditions: recent ventriculotomy or atriotomy heart surgery; prosthetic valves; active systemic infection; use in coronary vasculature; myxoma or intracardiac thrombus, transseptal approach with an interatrial baffle or patch; retrograde trans-aortic approach in patients with aortic valve replacement. Warnings: It is important to carefully titrate RF power; too high RF power during ablation may lead to perforation caused by steam pop. Contact force in excess of 70 g may not improve the characteristics of lesion formation and may increase the risk for perforation during manipulation of the catheter. Monitor applied contact force during procedure to avoid applying excessive force. Patients undergoing septal accessory pathway ablation are at risk for complete AV block which requires the implantation of a permanent pacemaker. Implantable pacemakers and implantable cardioverter/defibrillator may be adversely affected by RF current. 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. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. Precautions: The long-term risks of protracted fluoroscopy and creation of RF induced lesions have not been established; careful consideration must be given for the use of the device in prepubescent children. When using the catheter with conventional EP lab system or with a 3-D navigational system, careful catheter manipulation must be performed, in order to avoid cardiac damage, perforation, or tamponade. Always maintain a constant saline irrigation flow to prevent coagulation within the lumen of the catheter. Care should be taken when ablating near structures such as the sino-atrial and AV nodes. Potential Adverse Events: Potential adverse events include, but are not limited to, cardiovascular related complications, including groin hematoma, pericardial effusion and infection. More serious complications are rare, which can include damage to the heart or blood vessels; blood clots (which may lead to stroke); tamponade; severe pulmonary vein stenosis; heart attack; esophageal fistula, or death.