VERSACROSS CONNECT LAAC ACCESS SOLUTION

Additional Manufacturer Narrative

DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. IT WAS NOT AVAILABLE BECAUSE THE HEALTHCARE FACILITY IS UNAVAILABLE TO PROVIDE THE LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT PERICARDIAL EFFUSION, CARDIAC PERFORATION OCCURRED. DURING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE USING A WATCHMAN FLX PRO IN A PATIENT WITH ATRIAL FIBRILLATION, VERSACROSS CONNECT PIGTAIL RF WIRE WAS USED WITH A NON-BOSTON SCIENTIFIC SHEATH AND CATHETER TO PERFORM TRANSSEPTAL PUNCTURE. THE INITIAL ATTEMPT TO ADVANCE THE NON-BOSTON SCIENTIFIC SHEATH ACROSS THE SEPTUM WAS UNSUCCESSFUL. THE VERSACROSS PIGTAIL RF WIRE WAS WITHDRAWN INTO THE RIGHT ATRIUM, AND A SECOND TRANSSEPTAL PUNCTURE WAS PERFORMED INFERIOR TO THE ORIGINAL PUNCTURE SITE. FOLLOWING SUCCESSFUL TRANSSEPTAL PUNCTURE USING THE VERSACROSS PIGTAIL RF WIRE, THE NON-BOSTON SCIENTIFIC SHEATH, PIGTAIL CATHETER WERE ADVANCED. CONTRAST INJECTION DEMONSTRATED CONTRAST WITHIN THE PERICARDIAL SPACE, RESULTING PERICARDIAL EFFUSION. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) CONFIRMED COMPRESSION OF THE HEART DUE TO FLUID ACCUMULATION WITHIN THE PERICARDIAL SPACE. A PERICARDIOCENTESIS WAS PERFORMED, AND BRIGHT RED BLOOD WAS ASPIRATED AND TRANSFUSED BACK TO THE PATIENT. AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE DEVICE WAS IMPLANTED. THE REPORTED PERFORATION SITE WAS THE POSTERIOR WALL; HOWEVER, A SPECIFIC PERFORATION POINT WAS NOT VISUALIZED. THE PATIENT WAS RECEIVING PLAVIX THERAPY. THE PLANNED LAA CLOSURE DEVICE WAS NOT DEPLOYED, AND NO SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS MANAGED WITH PERICARDIOCENTESIS AND ASD CLOSURE DEVICE PLACEMENT.