VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE

Additional Manufacturer Narrative

IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION (RETAINED BY CUSTOMER). IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE WAS SELECTED FOR PULMONARY VEIN ISOLATION PROCEDURE. DURING THE INSERTION, PHYSICIAN INTRODUCED THE FARADRIVE ON THE WIRE, IT WAS ENCOUNTERED A PART OF THE WIRE GOT KINKED AND COATING MADE UNABLE TO PASS FARADRIVE THROUGH. THE INSULATION WAS DAMAGED AND DETACHED. THE WIRE INSULATION STRIP OFF AT PROXIMAL END. THE PHYSICIAN DID FEEL LIKE THE WIRE WAS GETTING CAUGHT WHILE RETRACTING, REQUIRING THEM TO PULL WITH EXCESSIVE FORCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING DIFFERENT DEVICE, SAME MODEL. NO PATIENT COMPLICATION WAS REPORTED.