CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER

Description of Event or Problem

AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN FILTER, THE PIN VISE SEPARATED FROM A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S SNARE. THE FEET/LEGS OF THE FILTER, WHICH HAD BEEN IN PLACE FOR FIVE MONTHS, WERE NOT EMBEDDED IN THE CAVAL WALL. THE HOOK OF THE FILTER WAS CAPTURED WITH THE SNARE AND THE USER BEGAN TO "SHEATH" THE FILTER, WHILE APPLYING BACK TENSION ON THE SNARE. THE PIN VISE THEN SEPARATED AND THE ENTIRE SNARE CAME OUT OF THE CATHETER. THE SNARE WAS UNABLE TO BE RE-THREADED INTO THE TUOHY-BORST ADAPTER AND THEREFORE THE USER PLACED THE SNARE THROUGH THE SIDE-ARM. THE FILTER HOOK WAS SNARED AND THE FILTER WAS REMOVED FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1: CUSTOMER NAME AND ADDRESS. ADDRESS LINE 2: (B)(6) OR H3: DEVICE EVALUATED BY MFG OTHER (81). DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN FILTER, THE PIN VISE SEPARATED FROM A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S SNARE. THE FEET/LEGS OF THE FILTER, WHICH HAD BEEN IN PLACE FOR FIVE MONTHS, WERE NOT EMBEDDED IN THE CAVAL WALL. THE HOOK OF THE FILTER WAS CAPTURED WITH THE SNARE AND THE USER BEGAN TO "SHEATH" THE FILTER, WHILE APPLYING BACK TENSION ON THE SNARE. THE PIN VISE THEN SEPARATED, AND THE ENTIRE SNARE CAME OUT OF THE CATHETER. THE SNARE WAS UNABLE TO BE RE-THREADED INTO THE TUOHY-BORST ADAPTER AND THEREFORE THE USER PLACED THE SNARE THROUGH THE SIDE-ARM. THE FILTER HOOK WAS SNARED, AND THE FILTER WAS REMOVED FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE PIN VISE WAS SEPARATED FROM THE Y-FITTING AND THE SNARE WAS EXPANDED OUT OF THE CATHETER. THE SNARE WAS INSERTED INTO THE SIDE-ARM OF THE Y-FITTING INSTEAD OF THROUGH THE TUOHY-BORST VALVE. THE PIN VISE WAS NOT TIGHT TO THE SNARE WIRE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU STATES ¿NOTE: IF AT ANY TIME DURING THE PROCEDURE, THE DISTANCE BETWEEN THE PIN VISE AND THE CLEAR Y-FITTING CHANGES, THE SCREW AT THE TOP OF THE CLEAR Y-FITTING SHOULD BE FURTHER TIGHTENED.¿ A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A MANUFACTURING AND QUALITY CONTROL DEFICIENCY CONTRIBUTED TO THIS EVENT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.