BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    MDR report key: 9962119 · Received April 15, 2020

    Report

    Report Number
    1820334-2020-00822
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Date of Event
    April 23, 2019
    Report Date
    September 1, 2020
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    00827002132870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT: AS INITIALLY REPORTED, DURING RETRIEVAL OF AN UNKNOWN FILTER USING A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET, THE FILTER COLLAPSED BUT WAS DIFFICULT TO DISENGAGE FROM THE CAVAL WALL. THE FILTER WAS ULTIMATELY REMOVED SUCCESSFULLY WITH THE COMPLAINT DEVICE. UPON EVALUATION OF THE RETURNED DEVICE ON 18SEP2019, A SPLIT WAS FOUND ON THE DISTAL END OF THE BLUE RETRIEVAL SHEATH. 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, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. A COMPLETE COAXIAL RETRIEVAL SHEATH AND A COMPLETE RETRIEVAL LOOP SYSTEM EXCLUDING THE STOP COCK WAS RETURNED AND EVALUATED. THE SHEATH HAD A COMPRESSED AREA, THE LOOP SYSTEM HAD A KINK AND THE RETRIEVAL CATHETER HAD A SPLIT IN THE DISTAL END. PER THE PRODUCT EVALUATION, THE LIKELY CAUSE FOR THE REPORTED EVENT COULD BE THAT THE FILTER WAS NOT FULLY COLLAPSED BEFORE THE SHEATH WAS ADVANCED OVER THE FILTER HENCE THE SPLIT IN THE DISTAL END. FURTHERMORE, THE COMPRESSED AREA IS MOST LIKELY CAUSED BY USE OF EXCESSIVE FORCE. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE EVIDENCE INDICATES THE PRODUCT WAS MADE TO SPECIFICATIONS. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. IT WAS DETERMINED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE INITIAL RELEASE, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. NO GAPS WERE DISCOVERED IN THE QUALITY CONTROL PROCEDURES FOR THIS DEVICE. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. AN IFU IS PROVIDED WITH THIS DEVICE, WHICH WARNS ¿EXCESSIVE FORCE SHOULD NOT BE USED TO RETRIEVE THE FILTER.¿ THE IFU GOES ON TO NOTE ¿WHILE HOLDING THE RETRIEVAL LOOP AND CLEAR Y-FITTING STEADY, ADVANCE THE WHITE TUOHY-BORST SIDE-ARM ADAPTER WITH THE COAXIAL RETRIEVAL SYSTEM. THE FILTER COLLAPSES AND THE HOOKS DISENGAGE FROM THE CAVAL WALL¿WHEN THE TIP OF THE COAXIAL RETRIEVAL SYSTEM IS AT THE BARBED HOOKS, LOOSEN THE HUB OF THE BLUE OUTER SHEATH, ADVANCE THE OUTER SHEATH FORWARD TO COVER THE WHOLE FILTER, AND RETRIEVE THE COMPLETE ASSEMBLY.¿ BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT THE LIKELY CAUSE FOR THE REPORTED EVENT COULD BE THAT THE FILTER WAS NOT FULLY COLLAPSED WHEN THE SHEATH WAS ADVANCED OVER THE FILTER THUS THE DIFFICULTY IN DISENGAGING THE FILTER FROM CAVAL WALL. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 · 0

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

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. COMMON NAME & PRODUCT CODE = DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR. OCCUPATION = UNKNOWN. PMA/510(K) NUMBER = K073374. 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.

    Description of Event or Problem · 1

    AS INITIALLY REPORTED, DURING RETRIEVAL OF AN UNKNOWN FILTER USING A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET, THE FILTER COLLAPSED BUT WAS DIFFICULT TO DISENGAGE FROM THE CAVAL WALL. THE FILTER WAS ULTIMATELY REMOVED SUCCESSFULLY WITH THE COMPLAINT DEVICE. UPON EVALUATION OF THE RETURNED DEVICE ON 18SEP2019, A SPLIT WAS FOUND ON THE DISTAL END OF THE BLUE RETRIEVAL SHEATH. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429513 GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK COOK INC G13287 9585063 00827002132870

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR