GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

SUMMARY OF EVENT: AS REPORTED, DURING A PROCEDURE INVOLVING RETRIEVAL OF AN UNKNOWN FILTER, THE SNARES OF TWO GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SETS BROKE OFF INSIDE THE PATIENT (REPORTED UNDER PATIENT IDENTIFIERS (B)(6)). PER THE REPORTER, THE PHYSICIAN WAS BEING TOO AGGRESSIVE DURING RETRIEVAL ATTEMPTS, WHICH IS BELIEVED TO HAVE CONTRIBUTED TO THE DEVICES BREAKING. ONE SNARE WAS SUCCESSFULLY RETRIEVED, AND THE OTHER SNARE FRAGMENT REMAINED IN THE PATIENT, LIKELY HOOKED WITHIN THE FILTER. IT IS UNKNOWN HOW THE RETRIEVED SNARE WAS RECOVERED. ONE OF THE RETRIEVAL SETS¿ BLUE OUTER SHEATHS ALSO SEPARATED FROM THE WHITE HUB; HOWEVER, IT IS UNKNOWN IF THE HUB SEPARATED BEFORE OR AFTER THE SNARE BROKE, AND IT IS UNKNOWN WHICH SET WAS INVOLVED. THE PROCEDURE WAS ABORTED. ALTHOUGH IT IS UNKNOWN WHICH SNARE FRAGMENT REMAINS IN THE PATIENT, THE SERIOUS INJURY WAS REPORTED UNDER PATIENT IDENTIFIER (B)(6). CORRECTED INFORMATION: H6 (ANNEX A). INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED TO COOK; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU STATES THAT THE GTRS IS DESIGNED FOR RETRIEVAL OF TULIP AND CELECT FILTERS AND THAT EXCESSIVE FORCE SHOULD NOT BE EXERTED TO COLLAPSE/RETRIEVE THE FILTER. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE IFU AND LABEL. 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 AND IFU 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 DEFINITIVE CAUSE FOR THE EVENT CANNOT BE DETERMINED; HOWEVER, IT IS POSSIBLE THAT RETRIEVAL OF A NON-COOK FILTER OR EXCESSIVE FORCE EXERTED TO CATCH/COLLAPSE/RETRIEVE THE UNKNOWN FILTER MAY HAVE CONTRIBUTED TO THE 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.

Additional Manufacturer Narrative

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 A PROCEDURE INVOLVING RETRIEVAL OF AN UNKNOWN FILTER, THE SNARES OF TWO GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SETS BROKE OFF INSIDE THE PATIENT (REPORTED UNDER PATIENT IDENTIFIERS (B)(6). PER THE REPORTER, THE PHYSICIAN WAS BEING TOO AGGRESSIVE DURING RETRIEVAL ATTEMPTS, WHICH IS BELIEVED TO HAVE CONTRIBUTED TO THE DEVICES BREAKING. ONE SNARE WAS SUCCESSFULLY RETRIEVED, AND THE OTHER SNARE FRAGMENT REMAINED IN THE PATIENT, LIKELY HOOKED WITHIN THE FILTER. IT IS UNKNOWN HOW THE RETRIEVED SNARE WAS RECOVERED. ONE OF THE RETRIEVAL SETS¿ BLUE OUTER SHEATHS ALSO SEPARATED FROM THE WHITE HUB; HOWEVER, IT IS UNKNOWN IF THE HUB SEPARATED BEFORE OR AFTER THE SNARE BROKE, AND IT IS UNKNOWN WHICH SET WAS INVOLVED. THE PROCEDURE WAS ABORTED. ALTHOUGH IT IS UNKNOWN WHICH SNARE FRAGMENT REMAINS IN THE PATIENT, THE SERIOUS INJURY WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(6).