VERSACROSS CONNECT LAAC ACCESS SOLUTION

Additional Manufacturer Narrative

PATIENT INFORMATION WAS NOT AVAILABLE AT THE FACILITY.

Description of Event or Problem

A VERSACROSS CONNECT LAAC ACCESS SOLUTION WAS SELECTED FOR USE IN A WATCHMAN IMPLANT PROCEDURE. IT WAS REPORTED THAT THE RF WIRE HAD ITS COATING DAMAGED, WHICH PREVENTED ITS INSERTION INTO THE DILATOR. AS A RESULT, AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED, AND THE PATIENT FULLY RECOVERED. THE INSULATION DAMAGE WAS DISCOVERED DURING PREPARATION ON THE BACK TABLE. A DOUBLE CURVE SHEATH WAS USED AS AN ACCESSORY DEVICE IN THIS CASE, AND NO DAMAGE WAS OBSERVED THAT COULD HAVE CONTRIBUTED TO THE COATING ISSUE. NO OTHER ACCESSORY DEVICES WERE USED WITH THE VERSACROSS WIRE ASIDE FROM THE VERSACROSS DILATOR.