ANASTOCLIP AC CLOSURE SYSTEM

Additional Manufacturer Narrative

WE HAVE NOT RECEIVED THE DEVICE FOR INVESTIGATION. THEREFORE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. PER THE IFU: "SQUEEZE THE LEVERS TOGETHER FULLY UNTIL A DISCERNIBLE CLICK IS FELT. FAILURE TO SQUEEZE THE LEVERS COMPLETELY CAN RESULT IN CLIP MALFORMATION AND POSSIBLE BLEEDING OR LEAKAGE. CHECK TIGHTNESS OF CLIP PLACEMENT. TISSUE SHOULD COMPLETELY FILL CLIP OPENING AND CLIP SHOULD NOT LOOSELY ROCK SIDE TO SIDE." THE LOT HISTORY RECORD FOR THE DEVICE WAS REVIEWED, NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. DUE TO THE INCREASED RATE OF OCCURRENCE OF THIS ISSUE, CAPA 2022-033 HAS PREVIOUSLY BEEN IMPLEMENTED TO REDUCE THE OCCURRENCE OF THIS ISSUE. NOTE: THIS IS REPORT 1 OF 5 RELATED TO THE FIRST DEVICE USED IN THE EVENT. REPORTS 1220948-2024-00151, 1220948-2024-00152, 1220948-2024-00153, AND 1220948-2024-00154 WERE SUBMITTED FOR THE SECOND, THIRD, FOURTH, AND FIFTH DEVICES INVOLVED IN THIS EVENT.

Description of Event or Problem

IN 5 DIFFERENT SURGERIES PERFORMED THIS YEAR, IT WAS REPORTED THAT THE CEREBROSPINAL FLUID LEAK OCCURRED AT THE LOCATION WHERE THE ANASTOCLIP DEVICE WAS USED. DURING THE SURGERY, THE LEVER OF ANASTOCLIP AC WAS HELD FIRMLY AND THE CLIPS WERE SECURELY ATTACHED TO THE DURA MATTER. HOWEVER, ON THE DAY AFTER SURGERY, IT FOUND THAT A LIQUID LIKE WATER LEAKED FROM THE ANASTOMOSIS. WHEN GRASPED THE CLIPS WITH TWEEZERS, IT SEEMS THAT IT CAME OFF EASILY. THE CLIPS WERE PLACED CLOSE TOGETHER SO THAT THERE WERE NO GAPS BETWEEN THEM. THERE WAS NO CHANGE IN TECHNIQUE FROM PREVIOUS METHODS. ADDITIONAL INFORMATION WAS REQUESTED BUT THE DOCTOR REFUSED TO PROVIDE ADDITIONAL DETAILS. NOTE: THIS IS REPORT 1 OF 5 RELATED TO THE FIRST DEVICE USED IN THE EVENT. REPORTS 1220948-2024-00151, 1220948-2024-00152, 1220948-2024-00153, AND 1220948-2024-00154 WERE SUBMITTED FOR THE SECOND, THIRD, FOURTH, AND FIFTH DEVICES INVOLVED IN THIS EVENT.