BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    MDR report key: 1844782 · Received September 21, 2010

    Report

    Report Number
    1820334-2010-00474
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 23, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE DEVICE IN A USED CONDITION WAS RETURNED. ALONG WITH THE BROKEN DEVICE, ONLY THE SHEATH WAS RETURNED. AN EXAMINATION FOUND THAT THE DISTAL PORTION OF THE SNARE WAS SEPARATED APPROXIMATELY 2 CM PROXIMAL TO THE LOOP OF THE SNARE. THERE IS NO DAMAGE OBSERVED ON THE SHEATH. THIS DEVICE IS SHIPPED WITH AN IFU THAT LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU ADVISES THAT EXCESSIVE FORCE SHOULD NOT BE USED TO RETRIEVE THE FILTER. AS THE FILTER HAS BEEN IMPLANTED 37 DAYS, IT IS ESTIMATED THAT THE FILTER WAS ATTACHED IN THE VENA CAVA WALL IN SUCH A WAY THAT THE FRACTURE OF THE ANGLED WIRE LOOP RETRIEVER COULD HAVE OCCURRED DUE TO THE BACK AND FORTH MOVEMENTS MADE TO LOOSEN THE FILTER. IT IS POSSIBLE THAT EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THIS DEVICE DURING THE PROCEDURE. MOST LIKELY THE WIRE WAS BENT IN 180 DEGREES, CAUSING STRESSES TO THE WIRE AND FRACTURE OF THE SILVER SOLDERING. A REVIEW OF RECORDS FOUND NO OTHER COMPLAINTS ASSOCIATED WITH THE MANUFACTURE LOT OF THIS DEVICE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL.

    Description of Event or Problem · 1

    AFTER INITIAL FLUORO RUN, IT WAS DISCOVERED THAT THE IVC (INFERIOR VENA CAVA) FILTER WAS TILTED. THE PHYSICIAN WENT IN TO REMOVE THE FILTER AND AFTER TRYING TO RETRIEVE THE FILTER A FEW TIMES, THE SNARE OF THE RETRIEVAL SET SNAPPED OFF AND WAS SEPARATED FROM THE REMOVAL WIRE/CATHETER SYSTEM. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SNARE AND IT TOOK 2-3 HOURS TO REMOVE THE SNARE WITH ALLIGATOR FORCEPS. IN ORDER TO REMOVE THE SNARE THEY HAD TO GET ACCESS TO THE RIGHT INTERNAL JUGULAR AND RIGHT FEMORAL VEINS. AFTER REMOVING THE LOOP SNARE, THEY DECIDED TO LEAVE THE FILTER IN THE PATIENT AS THE FAMILY HAD BEEN THERE FOR SEVERAL HOURS. THEY DECIDED TO BRING THE PATIENT BACK AT A LATER DATE (TBD) TO REMOVE THE FILTER. PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK, INC. NA 2520172

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention