Description of Event or Problem · 0
THE PATIENT HAD A PERICARDIAL EFFUSION. THE EFFUSION WAS DISCOVERED USING INTRACARDIAC ECHO DURING A ROUTINE CHECK POST PULLING THE TRANSSEPTAL SHEATH BACK INTO THE RIGHT ATRIUM. THE PFA WAS COMPLETED INVOLVING PULMONARY VEIN ISOLATION AND APPLICATIONS TO THE POSTERIOR WALL WITH THE BOSTON SCIENTIFIC FARAWAVE CATHETER. A PERICARDIOCENTESIS WAS COMPLETED WITH APPROXIMATELY 150CC BLOOD REMOVED. THE PATIENT REMAINED STABLE AND THERE WAS NO CHANGE IN THE PATIENT'S BLOOD PRESSURE. THE PERICARDIAL DRAIN WAS LEFT IN PLACE AND THE PATIENT WAS STABLE ON TRANSFER TO THE INTENSIVE CARE UNIT (ICU) FOR FURTHER MONITORING. THE PHYSICIAN WAS NOT SURE OF THE CAUSE OF THE PERICARDIAL EFFUSION. THE PATIENT HAD A PERSISTENT SVC WHICH MADE TRANSSEPTAL ACCESS DIFFICULT. THE PHYSICIAN USED INTRACARDIAC ECHO TO CHECK FOR EFFUSION POST TRANSSEPTAL WHICH WAS NEGATIVE AT THE TIME. BWI CATHETERS USED WERE SIEMANS SOUNDSTAR10FR (10438577 LOT G5206610), CORONARY SINUS (BD710FJ282RTS LOT 31604275M) AND OPTRELL 36 POLE D/F CURVE (D142901 LOT 31537153M) NON BWI CATHETERS USED WERE THE BOSTON SCIENTIFIC FARAWAVE AND THE BOSTON SCIENTIFIC VERSACROSS SHEATH. SYSTEMS USED WERE THE CARTO SN (B)(6) SOFTWARE VERSION: 8.1.0.325, SMARTABLATE GENERATOR SN (B)(6), SOFTWARE VERSION 1.7. (CALLER STATES THAT THE GENERATOR WAS NOT USED DURING THE PROCEDURE) AND PFA WITH BOSTON SCIENTIFIC FARAPULSE SYSTEM USED. PATIENT: 3271. DEVICE: 2682. REFERENCE REPORT: MW5176463. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).