Description of Event or Problem · 0
PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6). NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6), INC. PRODUCT. IT WAS REPORTED THAT A PERFORATION LEADING TO A PERICARDIAL EFFUSION OCCURRED DURING THE PROCEDURE. THE PHYSICIAN NOTICED THE PATIENT'S ARTERIAL PRESSURE HAD DROPPED IN THE MIDDLE OF THE CASE JUST AFTER THE SECOND TRANSSEPTAL. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PROCEDURE WAS ABORTED. NO ABLATION HAD BEEN PERFORMED YET. A PERICARDIAL WINDOW WAS PERFORMED AS THE MEDICAL INTERVENTION. THE PATIENT'S LAST KNOWN STATUS WAS STABLE AND IN THE INTENSIVE CARE UNIT (ICU). THE FOLLOWING THERAPEUTIC/DIAGNOSTIC BWI PRODUCTS WERE IN USE: DECANAV CATHETER (R7F282CT / AD24380046) AND SOUNDSTAR ICE CATHETER STERILMED (R10439011 / 2222835). ADDITIONAL INFORMATION WAS RECEIVED STATING SL1 AND SL2 SHEATHS WERE USED FOR THE TRANSSEPTAL PUNCTURE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5167431.