VERSACROSS CONNECT LAAC ACCESS SOLUTION

Additional Manufacturer Narrative

GOOD FAITH EFFORT ATTEMPTS ARE IN PROGRESS TO RETRIEVE THE DEVICE STATUS, BUT IT HAS NOT BEEN OBTAINED YET. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. GOOD FAITH EFFORTS TO OBTAIN THE INFORMATION ARE IN PROGRESS. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED IF THE INFORMATION IS RECEIVED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC TAMPONADE, PERICARDIAL EFFUSION, HYPOTENSION, AND REDUCED NEUROLOGICAL STATUS. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE A VERSACROSS CONNECT LAAC ACCESS SOLUTION RF WIRE WAS USED. WHEN PERFORMING THE TRANSSEPTAL PUNCTURE (TSP) MULTIPLE DROP DOWNS WERE REQUIRED TO GET IDEAL POSITION ON THE SEPTUM. DURING TWO OF THESE ATTEMPTS THERE WAS EVIDENCE THAT THE RF WIRE SEEMED TO SLIP INTO THE LEFT ATRIUM (LA) THROUGH A SMALL OPENING, BUT NO FURTHER DILATION WAS PERFORMED SINCE THE OPENING WAS NOT IN AN IDEAL SPOT. THE TSP WAS PERFORMED INFERIOR AND POSTERIOR BEFORE MOVING ON TO THE LAAC, WHICH WAS COMPLETED WITHIN TWENTY-FIVE MINUTES POST-TSP. A TRIVIAL PERICARDIAL EFFUSION AROUND THE RIGHT SIDED CHAMBERS WAS NOTED ON ECHOCARDIOGRAPHY AT THE END OF THE PROCEDURE, BUT IT WAS NOT DEEMED A CONCERN. WHEN THE PATIENT WAS IN RECOVERY A DROP IN BLOOD PRESSURE OCCURRED AND THE PATIENT BECAME LESS RESPONSIVE. A PERICARDIAL TAP WAS PERFORMED WHICH REMOVED MORE THAN 150CC OF FLUID AND THE PATIENT'S CONDITION IMPROVED. THE PATIENT WAS HOSPITALIZED BUT IS EXPECTED TO FULLY RECOVER.