Description of Event or Problem · 1
ON (B)(6) 2014, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS AND TRANSFUSION DURING A CARDIAC ABLATION PROCEDURE. THE ABLATION DEVICE, IN ITS OWN SHEATH, WAS LOCATED IN THE LEFT ATRIAL APPENDAGE. THE PHYSICIAN STRUGGLED WITH DEPLOYMENT OF THE 70MM FIRMAP CATHETER, BUT SUCCESSFULLY DEPLOYED IT USING A DEFLECTABLE SHEATH. A SINGLE LEFT ATRIAL MAP WAS TAKEN WITH THE 70MM FIRMAP. DURING MAP REVIEW, THE PHYSICIAN NOTICED THAT A SYSTEMIC BLOOD PRESSURE DROP OCCURRED. THE PATIENT EXPERIENCED PERICARDIAL EFFUSION DUE TO WHAT WAS LATER DESCRIBED AS A "WIRE HOLE" PERFORATION IN THE LEFT ATRIAL APPENDAGE CAUSED MECHANICALLY BY THE ABLATION CATHETER. THE PATIENT REQUIRED PERICARDIOCENTESIS AND TRANSFUSION. APPROXIMATELY 1500CC OF BLOOD IN TOTAL WERE DRAINED. THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM FOR DEFINITIVE SURGERY, SUTURE CLOSURE OF THE PERFORATION IN THE LEFT ATRIAL APPENDAGE. FOLLOWING TREATMENT THE PATIENT WAS REPORTED TO BE IN STABLE AND GOOD CONDITION. REFERENCE MFR # 3008497357-2014-00002.