BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI JUGULAR SYSTEM

    MDR report key: 4092399 · Received September 5, 2014

    Report

    Report Number
    2020394-2014-00405
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A VENA CAVA FILTER, THE FILTER TILTED. THE FILTER REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545937 DENALI JUGULAR SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. GFXE3636

    Patients

    Seq Age Sex Outcome Treatment
    1