Description of Event or Problem · 0
DURING A VT (VENTRICULAR TACHYCARDIA) PROCEDURE, THE AORTA WAS PERFORATED BY THE (B)(6) WIRE (SAFESEPT) WHICH REQUIRED SURGERY AND THE PATIENT SUBSEQUENTLY DIED. THE PATIENT WAS HIGH RISK AND HAD MULTIPLE MORBIDITIES. DURING TRANSSEPTAL PUNCTURE WITH THE AGILIS SHEATH, BRK (BROCKENBROUGH) NEEDLE, AND A NON-ABBOTT (SAFESEPT WIRE), THE PHYSICIAN PUNCTURED THE AORTA WITH THE SAFESEPT. HE IMMEDIATELY PULLED BACK THE WIRE. HE TRIED AGAIN AND THIS TIME THE PUNCTURE WAS RIGHT BUT HE COULD NOT PUSH THE AGILIS DILATOR OVER THE HOLE. HE THEN TRIED A 3RD TIME AND WAS ABLE TO DO A SUCCESSFUL TRANSSEPTAL PUNCTURE. AFTER ADVANCING THE ADVISOR HD (HIGH DENSITY) GRID CATHETER THROUGH THE AGILIS SHEATH IN THE LV (LEFT VENTRICLE) HE ASKED THE ATTENDING CO PHYSICIAN TO DO A CARDIAC ULTRASOUND. THEREBY A PERICARDIAL EFFUSION WAS DIAGNOSED. BLOOD PRESSURE DROPPED TO 60/30. A PERICARDIOCENTESIS WAS PERFORMED AND THE REANIMATION TEAM AND CHIEF PHYSICIANS AND HEART SURGERY WERE CONTACTED. THE CHIEF OF EP (ELECTROPHYSIOLOGY) TOOK OVER AND WAS ABLE TO PULL OUT LARGE AMOUNTS OF BLOOD. BLOOD PRESSURE STABILIZED TO 120/80. THE PHYSICIAN COULD NOT NO LONGER REMOVE ANY MORE BLOOD. PROTAMIN WAS GIVEN, HOWEVER THE PERICARDIUM WAS FILLING AGAIN WITH BLOOD, WHICH CLOTTED AND WAS NOT ABLE TO BE PULLED OUT. BLOOD PRESSURE DROPPED TO NEAR ZERO. CPR (CARDIOPULMONARY RESUSCITATION) WAS THEN STARTED. CARDIAC SURGEONS OPENED THE THORAX AND PERFORMED EMERGENCY SURGERY TO FIND AN UNRESPONSIVE HEART WHICH HAD A PERFORATED AORTA. THEY WERE ABLE TO RETRIEVE A BIG AMOUNT OF COAGULATED BLOOD SURROUNDING THE HEART. PATIENT WAS THEN DECLARED DEAD. PATIENT IS NOW IN PATHOLOGY FOR OBDUCTION. THE PHYSICIAN CONFIRMED THAT THE (B)(6) DEVICE (SAFESEPT WIRE) PUNCTURED THE AORTA AND THE PUNCTURED AORTA WAS THE CAUSE OF THE PATIENT'S DEATH. THERE WERE NO PERFORMANCE ISSUES WITH ANY (B)(6) DEVICE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN FORM OF A NOTIFICATION PER 803.22 (B)(2).