BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP VENA CAVA FILTER

    MDR report key: 10605923 · Received September 29, 2020

    Report

    Report Number
    MW5096953
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 17, 2020
    Report Date
    September 25, 2020
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THERE WAS MOVEMENT SEEN OF THE IVC FILTER AFTER DEPLOYMENT BUT BEFORE SHEATH WAS REMOVED FROM BODY. IT APPEARED THE FILTER WAS STILL TETHERED TO THE DEPLOYMENT DEVICE. RELEASE BUTTON WAS PUSHED MULTIPLE TIMES BEFORE FILTER WAS RELEASED FROM SHEATH. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065749 GUNTHER TULIP VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK MEDICAL LLC IGTCFS-65-1-JUG-TULIP E3938436

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR