ACUNAV ICE CATHETER

Description of Event or Problem

THE PROCEDURE WAS CRYO AF(ATRIAL FIBRILLATION). TYPICAL PROTOCOLS WERE PERFORMED (GENERAL ANESTHESIA, MAPPING, PHRENIC PACING, ETC.). CASE WAS MAPPED WITH ENSITE X, NAVX MODE. THE CATHETERS IN THE BODY: INNOVATIVE HEALTH REPROCESSED DYNAMIC XT DECA, INNOVATIVE HEALTH REPROCESSED ACHIEVE CATHETER, FLEXCATH, ARTICFRONT BALLOON, AND STERILMED ACUNAV ICE. TRANSEPTAL PUNCTURE WAS DONE WITH THE FLEXCATH CROSS AND THE FLEX CATH SHEATH. ALL PULMONARY VEINS WERE ISOLATED VIA FREEZING WITH CRYO BALLOON. NO INTRAOPERATIVE COMPLICATIONS WERE OBSERVED. IMMEDIATELY POST-OPERATION, PATIENT WAS HYPOTENSIVE AND HYPOXIC. ATTEMPTS AT RESUSCITATION WERE PERFORMED BY HOSPITAL PERSONNEL, BUT WERE NOT SUCCESSFUL. NO FAULT HAS BEEN ATTRIBUTED TO ANY (B)(6) PRODUCTS OR TO ANY PRODUCTS USED DURING THE CASE. ONLY (B)(6) PRODUCT INVOLVED IN THE CASE WERE ENSITE X PATCHES. REFERENCE REPORTS: MW5153775, MW5153776, MW5153777, MW5153778, MW5153779. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).