Description of Event or Problem · 0
DURING AN ATRIAL FIBRILLATION PROCEDURE FOR PVI, A PERICARDIAL EFFUSION OCCURRED AND THE PATIENT EXPIRED. THE DIAGNOSTIC CATHETERS WERE PLACED IN THE HIS AND RIGHT ATRIUM CORONARY SINUS POSITION AND TRANSSEPTAL PUNCTURE WAS DONE SUCCESSFULLY. AFTERWARDS THE MAPPING CATHETER WAS PLACED IN THE LEFT ATRIUM AND STEERING WAS NOTED TO BE DIFFICULT. A CARDIAC ULTRASOUND SHOWED A PERICARDIAL EFFUSION IN THE PATIENT. A PERICARDIOCENTESIS WAS THEN PERFORMED. DURING THE NEXT HOUR APPROXIMATELY 1.5 LITERS BLOOD WERE WITHDRAWN FROM THE PERICARDIUM. THE EMERGENCY TEAM ENTERED THE ROOM AND SOON THE PATIENT SHOWED ASYSTOLE. THE EMERGENCY TEAM BEGAN WITH CPR, HOWEVER THE PATIENT DID NOT RECOVER AND EXPIRED IN THE CATH LAB. THE PHYSICIAN STATED THAT THERE WERE NO PRODUCT PERFORMANCE ISSUES WITH ANY (B)(6) PRODUCTS USED IN THIS CASE. ACCORDING TO THE PHYSICIAN THE CAUSE OF THE EFFUSION AND OF THE PATIENT'S DEATH ARE NOT CLEARLY KNOWN BUT THAT THE PERFORATION COULD HAVE POTENTIALLY OCCURRED AFTER TRANSSEPTAL PUNCTURE ON THE LEFT ATRIUM ROOF. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".