VERSACROSS CONNECT LAAC ACCESS SOLUTION

Additional Manufacturer Narrative

DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. 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 A PATIENT EXPERIENCED A CARDIAC TAMPONADE. DURING A PROCEDURE, A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED. PROCEDURE WAS COMPLETED SUCCESSFULLY AND UNEVENTFULLY WITH VERSACROSS CONNECT ACCESS SOLUTION, TRUSTEER, AND WATCHMAN 31MM DEVICE. NO RECAPTURES, NO ODD OR SUSPECT BEHAVIOR FROM ANY PRODUCT DURING THE PROCEDURE. DURING PATIENT RECOVERY IT WAS REPORTED THAT THE PATIENT WAS IN TAMPONADE. PATIENT WAS BROUGHT TO CATHETER LAB AND TAPPED. ROUGHLY 300CC OF BLOOD WAS REMOVED FROM THE PERICARDIUM. PROTAMINE WAS GIVEN AND THE EFFUSION WAS OBSERVED FOR 10 MINUTES TO MAKE SURE IT HAD RESOLVED VIA SURFACE TRANSTHORACIC ECHOCARDIOGRAPHY. LATER, THE PHYSICIAN RETURNED TO THE RECOVERY AREA TO DO ANOTHER LIMITED ECHO ON THE PATIENT TO MAKE SURE IT WAS NOT STILL ACTIVE. THE EFFUSION HAD PERSISTED AND THE PATIENT WAS EXPERIENCING TAMPONADE AGAIN. IT WAS DECIDED TO SEND THE PATIENT TO SURGERY TO RESOLVE THE EFFUSION. CARDIOTHORACIC SURGERY WAS SUCCESSFUL AND FOUND A VERY SMALL HOLE ON ANTERIOR/SUPERIOR ASPECT OF THE LEFT ATRIUM. THE HOLE WAS CLOSED WITH A STITCH AND WAS DEEMED SUCCESSFUL. THE PATIENT WAS DISCHARGED AND ENTERED INTO CARDIAC REHAB.