CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER

Additional Manufacturer Narrative

(B)(6). DEVICE EVALUATED BY MFG - 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

AS REPORTED, DURING RETRIEVAL OF ANOTHER MANUFACTURER'S INFERIOR VENA CAVA FILTER, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S INNER SHEATH SPLIT. THE FILTER, WHICH HAD BEEN IN PLACE FOR APPROXIMATELY TWO MONTHS, WAS EMBEDDED IN THE CAVAL WALL. THE FILTER WAS SNARED; HOWEVER, IT WAS DIFFICULT TO RETRIEVE AND COLLAPSE. REPORTEDLY, THE CLOVER SNARE'S INNER SHEATH BENT AND THE SIDE OF THE SNARE CATHETER TORE. 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. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, THE INNER SHEATH WAS NOTED TO BE SPLIT.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING RETRIEVAL OF ANOTHER MANUFACTURER'S INFERIOR VENA CAVA FILTER, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER'S INNER SHEATH SPLIT. THE FILTER, WHICH HAD BEEN IN PLACE FOR APPROXIMATELY TWO MONTHS, WAS EMBEDDED IN THE CAVAL WALL. THE FILTER WAS SNARED; HOWEVER, IT WAS DIFFICULT TO RETRIEVE AND COLLAPSE. REPORTEDLY, THE CLOVER SNARE'S INNER SHEATH BENT AND THE SIDE OF THE SNARE CATHETER TORE. 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. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, THE INNER SHEATH WAS NOTED TO BE SPLIT. ADDITIONAL INFORMATION: E1 INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, 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 INNER SHEATH AND RETRIEVAL SNARE CATHETER WERE RETURNED TO COOK FOR INVESTIGATION. THE DISTAL END OF THE SHEATH WAS SPLIT OPEN AND KINKED. NO DAMAGE WAS NOTED TO THE RETRIEVAL SNARE CATHETER. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE WERE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE INSTRUCTION FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: ¿EXCESSIVE FORCE SHOULD NOT BE USED TO MANIPULATE OR RETRIEVE FOREIGN OBJECTS.¿ INSTRUCTIONS FOR USE: ¿STEP 6. ONCE THE FOREIGN OBJECT IS CAPTURED/SURROUNDED BY THE LOOPS OF THE SNARE, HOLD THE PIN VISE STEADY AND TIGHTEN THE SCREW OF THE Y-FITTING.¿ ¿STEP 7. WHILE HOLDING THE CLEAR Y-FITTING STEADY, ADVANCE THE COAXIAL SHEATH SYSTEM OVER THE FOREIGN OBJECT. NOTE: THE OUTER SHEATH OF THE COAXIAL SYSTEM MAY BE ADVANCED OVER THE TIP OF THE INNER SHEATH TO COVER ANY PORTION OF THE FOREIGN OBJECT NOT CONTAINED INSIDE THE DISTAL TIP OF THE INNER SHEATH.¿ COOK HAS 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. BASED ON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT AN ADVERSE EVENT RELATED TO THE PROCEDURE CAUSED THE DEVICE FAILURE. IT WAS REPORTED THAT THE FILTER WAS EMBEDDED IN THE CAVAL WALL MAKING IT DIFFICULT TO RETRIEVE AND COLLAPSE THE FILTER. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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.