BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP IVC FILTER

    MDR report key: 22884080 · Received August 25, 2025

    Report

    Report Number
    MW5175186
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    August 20, 2025
    Report Date
    August 20, 2025
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GUNTHER IVC FILTER FOUND TO BE MULTIPLY FRACTURED, WITH ONE LEG IN 2 PIECES PLUS PART OF THE THIN WIRES IN AN EXTRAVASCULAR LOCATION. THE FILTER WAS REMOVED WITH FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108210 GUNTHER TULIP IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Other| R| L