VERSACROSS CONNECT LAAC ACCESS SOLUTION

Description of Event or Problem

IT WAS REPORTED THAT A VERSACROSS CONNECT (VCC) LAAC ACCESS SOLUTION WAS SELECTED FOR USE DURING A LEFT ATRIAL APPENDAGE CLOSURE WITH WATCHMAN FLX PRO DEVICE PROCEDURE. DURING PROCEDURE, VERSACROSS WAS PROPERLY FLUSHED AND READY FOR USE WITH WATCHMAN FXD DOUBLE CURVE. THE VERSACROSS RF WIRE WAS SAFELY ADVANCED TO THE SUPERIOR VENA CAVA (SVC). WHILE IT WAS TRYING TO INSERT THE VERSACROSS SYSTEM, THE RF WIRE DID NOT SMOOTHLY PASS THROUGH THE VERSACROSS DILATOR AND GOT STUCK AT THE TIP OF THE DILATOR. IT WAS FURTHER NOTED THAT IT HAD APPEARED TO BE A PLASTIC FILM AT THE PROXIMAL END OF THE RF WIRE WHICH IMPEDED THE WIRE TO PASS SMOOTHLY THROUGH THE DILATOR. ALTERNATE VERSACROSS RF WIRE WAS PROVIDED, AND IT SMOOTHLY PASSED THROUGH THE SAME DILATOR ORIGINAL USED. PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS. RF WIRE WAS REPLACED.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.