EN SNARE®

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.

Description of Event or Problem

CUSTOMER ALLEGED A LOT OF RESISTANCE GETTING THE SNARE BACK INTO THE CATHETER. THE DOCTOR AND HIS PA REPORTED THEIR RETRIEVAL CATHETER WAS COILING LIKE A RUBBER BAND UNDER THE TENSION. THE SNARE AND THE WIRE THAT WE WERE SNARING WERE PARTIALLY ATTACHED TO THE VESSEL. THE SURGICAL TEAM CAME IN TO WORK THOUGH THE CUT DOWN AND PATCH THE HOLE THAT WAS MADE WHILE TRYING TO GET THE SNARE AND WIRE OUT OF THE VESSEL. SHE SAID THAT IT WAS ALMOST COILED LIKE A PIGTAIL BUT NOT QUITE THAT TIGHT.