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 HISTORY RECORD FOR THE DEVICE WAS REVIEWED, NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT.

Description of Event or Problem

IT WAS REPORTED THAT THE ANASTOCLIP GC CLIPS WERE MISFIRING. THE CLIP DEPLOYS WITHOUT COMPLETELY CLOSING SO THEY FALL OFF. DEVICE WAS NOT DIRECTLY USED ON PATIENT. NO INJURY WAS REPORTED.