ENDORE MOLLRING CUTTER TRASECTION DEVICE

Additional Manufacturer Narrative

WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. WE OBSERVED THE SHAFT OF THE MOLLRING CUTTER WAS BENT AND THE RINGS WERE MISALIGNED IN THE CLOSED POSITION. WE ALSO OBSERVED THE DISTAL END OF THE SHAFT OF THE MOLLRING CUTTER WAS CUT. DURING THE FOLLOW-UP INVESTIGATION, WE WERE INFORMED THAT THE RINGS OF THE CUTTER WERE BENT WHEN THE SURGEON ATTEMPTED TO CUT THE CALCIFIED SECTION OF THE ATHEROMA. AS A RESULT, THE RINGS WERE DAMAGED AND THE DEVICE WAS STUCK INSIDE THE PATIENT'S VESSEL. THIS REQUIRED THE SURGEON TO ABORT FEMORAL-POPLITEAL BYPASS AND PERFORM A OBTURATOR BYPASS SINCE THE EXTERNAL ILIAC ARTERY WAS DAMAGED BY THE DEVICE MALFUNCTION. AS STATED IN OUR IFU, THIS DEVICE IS NOT DESIGNED TO CUT CALCIFIED MATERIAL. THE IFU PROPERLY INSTRUCTS USERS NOT TO USE EXCESSIVE FORCE WITH THIS DEVICE TO STRIP AND/OR REMOVE PLAQUE SEGMENTS FROM AN OCCLUDED REGION. ATTEMPTED TRANSECTION OF SUCH MATERIAL MAY DAMAGE THE MOLLRING CUTTER TRANSECTION DEVICE. AS WITH ANY PROCEDURE, EXTREME CARE AND DISCRETION MUST BE EXERCISED AT ALL TIMES. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT. THEREFORE, WE BELIEVE THAT IT WAS AN ISOLATED INCIDENT.

Description of Event or Problem

EVENT DESCRIPTION: MOLLRING CUTTER DEVICE BENT WHILE TRYING TO PERFORM ILIOFEMORAL ENDARTERECTOMY. THIS REQUIRED THE SURGEON TO ABORT FEMORAL-POPLITEAL BYPASS AND CONVERT TO OBTURATOR BYPASS SINCE THE EXTERNAL ILIAC WAS BADLY DAMAGED BY DEVICE MALFUNCTION. THIS PUTS PATIENT AT INCREASED RISK OF INFECTION, BLEEDING AND RADIATION EXPOSURE DURING ASSESSMENT/REPAIR/POST SURGICAL COUNT POLICY, AND WILL PROBABLY PROLONG HOSPITALIZATION.