ANASTOCLIP GC CLOSURE SYSTEM - VASCULAR & NEURO

Additional Manufacturer Narrative

WE DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED MALFUNCTION. 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 NUMBER OF THE PRODUCT WAS NOT PROVIDED. THEREFORE, WE'RE UNABLE TO PERFORM A LOT REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT EVERY ANASTOCLIP GC (MEDIUM 8 MM) CLIPS WERE NOT COMPLETELY CLOSING, LOOSE OR FALLING OUT DURING A TETHERED CORD PROCEDURE. FAULTY CLIPS WERE NOT SAVED. NO INJURY WAS REPORTED WAS REPORTED TO THE PATIENT.