GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

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 INFERIOR VENA CAVA FILTER USING A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET, PART OF THE SNARE SEPARATED. THE COMPLAINT DEVICE WAS ADVANCED THROUGH THE JUGULAR VEIN. WHILE TURNING THE DEVICE, PART OF THE SNARE SEPARATED NEAR THE SNARE LOOP AND DISLODGED. ACCESS WAS THEN OBTAINED IN THE FEMORAL VEIN, REPORTEDLY IN CASE THE SEPARATED SNARE FRAGMENT MIGRATED AS THE FILTER WAS REMOVED. THE LEGS OF THE FILTER WERE THEN PURPOSEFULLY INTERTWINED WITH THE DISLODGED SNARE. THE FILTER WAS COLLAPSED, WITH THE SNARE ENTANGLED, AND ALL SNARE PIECES WERE REMOVED WITH THE FILTER, VIA THE JUGULAR ACCESS SITE. THE PATIENT 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 INFORMATION WAS RECEIVED 11MAY2023. THE OTHER MANUFACTURER'S FILTER WAS PLACED (B)(6) 2023 AND REMOVED (B)(6) 2023. INVESTIGATION EVALUATION: REVIEWS OF THE DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), AND SPECIFICATIONS 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 RETRIEVAL LOOP WAS SEPARATED AND TWISTED, AND SOME OF THE WIRES IN THE LOOP HAD A PLAIN CUT WHERE SEPARATED. THE MOST DISTAL TIP OF THE LOOP SYSTEM CATHETER WAS DAMAGED AND DENTED. 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 STATES THAT THE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET IS INTENDED FOR RETRIEVAL OF IMPLANTED COOK GUNTHER TULIP VENA CAVA FILTERS AND COOK CELECT VENA CAVA FILTERS IN PATIENTS WHO NO LONGER REQUIRE A FILTER. THE INFORMATION PROVIDED UPON REVIEW OF THE 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 ALTHOUGH THE EXACT CAUSE FOR LOOP SEPARATION COULD NOT BE DETERMINED, IT IS POSSIBLE THAT THE LOOP WAS EXPOSED TO STRONG MANIPULATION WHILE TURNING THE DEVICE, SUBSEQUENTLY SEPARATING DURING THE ATTEMPT TO CAPTURE/HOLD ON TO THE NON-COOK 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.

Description of Event or Problem

AS REPORTED, DURING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER USING A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET, PART OF THE SNARE SEPARATED. THE COMPLAINT DEVICE WAS ADVANCED THROUGH THE JUGULAR VEIN. WHILE TURNING THE DEVICE, PART OF THE SNARE SEPARATED NEAR THE SNARE LOOP AND DISLODGED. ACCESS WAS THEN OBTAINED IN THE FEMORAL VEIN, REPORTEDLY IN CASE THE SEPARATED SNARE FRAGMENT MIGRATED AS THE FILTER WAS REMOVED. THE LEGS OF THE FILTER WERE THEN PURPOSEFULLY INTERTWINED WITH THE DISLODGED SNARE. THE FILTER WAS COLLAPSED, WITH THE SNARE ENTANGLED, AND ALL SNARE PIECES WERE REMOVED WITH THE FILTER, VIA THE JUGULAR ACCESS SITE. THE PATIENT 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

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4: PMA/510(K) NUMBER = K181757. H3: (OTHER): THE DEVICE HAS BEEN RETURNED; HOWEVER, OUR INVESTIGATION IS ONGOING AND DEVICE EVALUATION SUMMARY WILL BE INCLUDED IN OUR FOLLOW UP REPORT ONCE OUR INVESTIGATION HAS BEEN COMPLETED. 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

ADDITIONAL INFORMATION WAS RECEIVED 11MAY2023. THE OTHER MANUFACTURER'S FILTER WAS PLACED 08FEB2023 AND REMOVED 30MAR2023.

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.