BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK MEDICAL IVC FILTER

    MDR report key: 3080017 · Received April 2, 2013

    Report

    Report Number
    3080017
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    COOK MEDICAL, INC
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IVC FILTER HAD TO BE RETRIEVED DUE TO THE LEGS BENDING THE WRONG WAY DURING A FEMORAL APPROACH. FILTER REMOVED AND REPLACED WITH SECOND FILTER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IVC FILTER PLACEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133843 COOK MEDICAL IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK MEDICAL, INC 8.5F X 65CM E2789884

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR