BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP

    MDR report key: 23693412 · Received December 2, 2025

    Report

    Report Number
    MW5179698
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 20, 2025
    Report Date
    November 25, 2025
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FAILED MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899702 GUNTHER TULIP FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK MEDICAL LLC G52916 E4734227

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female