GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. H3: (OTHER): 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. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED 07FEB2023. THE FILTER BEING RETRIEVED WAS A COOK CELECT FILTER.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INITIAL REPORTER OCCUPATION = RADIOLOGY TECH. PMA/510(K) NUMBER = K181757. 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 AN INFERIOR VENA CAVA (IVC) FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE SEPARATED IN THE PATIENT. THE UNKNOWN FILTER HAD BEEN IN PLACE FOR A FEW MONTHS. THE FILTER LEGS WERE NOT EMBEDDED IN THE IVC, AND THE USER DID NOT PULL, TUG, OR APPLY FORCE TO THE DEVICE. A 16-FRENCH COOK SHEATH AND ANOTHER MANUFACTURER'S SNARE WERE USED TO RETRIEVE THE FILTER AND THE SEPARATED PORTION OF THE SNARE. THE PATIENT WAS REPORTEDLY DOING WELL AND WAS DISCHARGED TO HOME AFTER THE PROCEDURE. 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

SUMMARY OF EVENT: AS REPORTED, DURING RETRIEVAL OF A COOK CELECT INFERIOR VENA CAVA (IVC) FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET'S SNARE SEPARATED IN THE PATIENT. THE FILTER HAD BEEN IN PLACE FOR A FEW MONTHS. THE FILTER LEGS WERE NOT EMBEDDED IN THE IVC, AND THE USER DID NOT PULL, TUG, OR APPLY FORCE TO THE DEVICE. A 16-FRENCH COOK SHEATH AND ANOTHER MANUFACTURER'S SNARE WERE USED TO RETRIEVE THE FILTER AND THE SEPARATED PORTION OF THE SNARE. THE PATIENT WAS REPORTEDLY DOING WELL AND WAS DISCHARGED TO HOME AFTER THE PROCEDURE. 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, DOCUMENTATION, AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DIMENSIONAL VERIFICATION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. KINKS WERE NOTED ON THE LOOP WIRE AND THE LOOP/SNARE WAS DETACHED. THE LOOP SYSTEM CATHETER WAS KINKED AND SQUEEZED. A DETAILED SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE FRACTURED ZONE SHOWED DIMPLES AND FATIGUE STRIATIONS, SUGGESTIVE OF DUCTILE FRACTURE, AND HIGH DEFORMATION, SUGGESTIVE OF COMPRESSION FORCE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU WARNS THAT EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER. 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. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT UNINTENDED USE ERROR CONTRIBUTED TO THIS EVENT. ALTHOUGH THE USER REPORTEDLY DID NOT PULL, TUG, OR APPLY FORCE TO THE DEVICE, THE DEVICE WAS RETURNED KINKED AND DAMAGED, WITH DIMPLES, FATIGUE STRIATIONS, AND HIGH DEFORMATION. THIS SUGGESTS THAT THE RETRIEVAL DEVICE WAS EXPOSED TO MANIPULATION BEYOND ITS INTENDED STRENGTH. THE IFU WARNS THAT EXCESSIVE FORCE SHOULD NOT BE EXERTED TO RETRIEVE THE FILTER. 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.

Description of Event or Problem

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