BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP VENA CAVA FILTER SET

    MDR report key: 24779652 · Received April 3, 2026

    Report

    Report Number
    1820334-2026-00361
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 19, 2026
    Report Date
    May 11, 2026
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: POSSIBLE MODEL AND CATALOG NUMBERS: G33016 IGTCFS-65-FEM; G33017 IGTCFS-65-JUG; OR G21360 IGTCFS-65-UNI. G4: PMA/510(K) NUMBER = K043509 OR K072240. 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 · 0

    AS REPORTED, AN UNSPECIFIED GUNTHER TULIP VENA CAVA FILTER, IMPLANTED IN 2005, WAS FOUND TO BE FRACTURED, WITH A THIN WIRE FRAGMENT STILL ATTACHED, BUT MOVING FREELY WITHIN THE INFERIOR VENA CAVA. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT WITH FORCEPS. THERE HAS BEEN NO REPORT THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62586 GUNTHER TULIP VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1