ANASTOCLIP GC CLOSURE SYSTEM - VASCULAR & NEURO

Description of Event or Problem

IT WAS REPORTED THAT DURING A BVT PROCEDURE, THE ANASTOCLIP GC CLIP APPLIER JAMMED AND STUCK ONTO THE PATIENT'S ARM AND COULD NOT GET IT TO RELEASE THE CLIP OR OFF THE PATIENT'S ARM. THEY HAD TO CUT OUT PART OF THE VEIN. DEVICE WAS CHECKED PRIOR TO USE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE OPERATION. NO OTHER ISSUES OR INJURY WERE REPORTED TO THE PATIENT.

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED FOR INVESTIGATION. DURING TESTING THE DEVICE, THE CLIPS WERE ABLE TO CLOSE COMPLETELY AND DEPLOYED PROPERLY FROM THE DEVICE. NO ISSUE OCCURRED DURING TESTING. THE CAUSE OF THE ISSUE DURING THE PROCEDURE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT AN INTERMITTENT ISSUE CAUSED THE CLIP TO BECOME STUCK DURING THE PROCEDURE. DUE TO SIMILAR REPORTED ISSUES, CAPA 2025-004 HAS BEEN INITIATED TO FURTHER INVESTIGATE AND ADDRESS THE ISSUE. NO FURTHER ACTION IS REQUIRED. THE LOT HISTORY RECORD FOR THE DEVICES 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.