BARD SNARE OUS

Additional Manufacturer Narrative

THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT THE DEVICE WAS RELATED TO A DEATH OR INJURY.

Description of Event or Problem

IT WAS REPORTED THAT DURING A VENA CAVA FILTER RETRIEVAL PROCEDURE, THE FRONT END OF THE LOOP LINE WAS ALLEGEDLY LOOSENING OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY'' '(B)(6) 2025 - IT WAS ORIGINALLY REPORTED IN THE EVENT DESCRIPTION, "PATIENT WAS ADMITTED TO THE HOSPITAL FOR LOWER EXTREMITY DEEP VEIN THROMBOSIS, PERFORMED "PERCUTANEOUS INFERIOR VENA CAVA FILTER REMOVAL", SELECTED MODEL SRK35 FILTER RECYCLER, THE OPERATOR'S OPERATING STANDARDS, IN THE PROCESS OF SENDING INTO THE BODY OF THE OPERATION OCCURS AT THE FRONT END OF THE LOOP LINE LOOSENING OFF, FAILED TO OPERATE TO TAKE OUT THE FILTER; OVERALL AFTER REMOVING THE FILTER, A NEW ONE WAS USED FOR THE OPERATION, AND THE OPERATION WENT SMOOTHLY, BUT THE OPERATOR SUSPECTED THAT THERE WAS A PRODUCT QUALITY MODE, AND REQUESTED TO FILE A COMPLAINT AND REPORT THE DAMAGE." THE EVENT DESCRIPTION WAS MODIFIED FOR CLARITY. THE DEVICE IS AVAILABLE FOR RETURN. CONFIRMED EVENT DATE WAS PRIOR TO EXPIRATION DATE IN JDE. EXPIRATION DATE FOR LOT 9017299808 IS 04/23/2027. A FOLLOW UP TASK CHILD WAS CREATED AND ASSIGNED TO THE IBC REQUESTING ADDITIONAL PATIENT AND PROCEDURAL DETAILS''. (B)(6).