BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT PLATINUM VENA CAVA FILTER SET FOR JUGULAR

    MDR report key: 15293566 · Received August 24, 2022

    Report

    Report Number
    MW5111710
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Report Date
    August 22, 2022
    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

    DEVICE DID NOT DEPLOY CORRECTLY- LOWER LEGS DID NOT OPEN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414345 COOK CELECT PLATINUM VENA CAVA FILTER SET FOR JUGULAR FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK MEDICAL LLC 1GTCFS-65-1 E4250678

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Other VENA CAVA FILTER SET FOR JUGULAR VEIN APPROACH