INVISIGRIP VEIN STRIPPER

Description of Event or Problem

DURING THE PROCEDURE, THE PHYSICIAN PULLED OUT THE ARTERY (SFA) BY MISTAKE. ACCORDING TO THE PHYSICIAN, THE PT'S ARTERY WAS TINY AND THERE WAS A LITTLE BLOOD BACKFLOW. AFTER THE PROCEDURE, THE PT WENT HOME, BUT FELT PAIN AND "COLDNESS" OF LEG. NEXT DAY AFTER THE PROCEDURE, THE PT WAS TAKEN TO THE EMERGENCY ROOM WHERE IT WAS FOUND THAT THE PT HAD ACUTE ARTERIAL OCCLUSIVE DISEASE AND PERFORMED EMERGENCY RE-VASCULARIZATION WITH SYNTHETIC VESSEL (GRAFT). PT IS RECOVERING. THIS INCIDENT WAS REPORTED TO (B)(4) SOCIETY OF PHLEBOLOGY, AND IT WAS NOTED THAT THIS INCIDENT WAS UNRELATED TO THE DEVICE, BUT THE DOCTOR'S TECHNIQUE. THE INCIDENT HAPPENED IN (B)(6) 2011 - (B)(6) 2012 TIME PERIOD.

Additional Manufacturer Narrative

WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION AND WERE NOT ABLE TO VERIFY THE FAILURE. BASED ON THE EVENT DESCRIPTION, THE MOST PROBABLE ROOT CAUSE OF THE INCIDENT WAS THE INCORRECT DOCTOR'S TECHNIQUE. THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESS AND THERE WERE NO UNRESOLVED ISSUES RELATED TO THE COMPLAINT EVENT. WE HAVE NOT SEEN THIS TYPE OF COMPLAINT BEFORE. THEREFORE, IT WAS AN ISOLATED INCIDENT. PLEASE NOTE THAT THE PT IS RECOVERING, AN THIS INCIDENT WAS NOT REPORTED TO THE MANUFACTURER BY THE HOSPITAL. THE INCIDENT BECAME KNOWN THROUGH THE (B)(4) SOCIETY OF PHLEBOLOGY.