BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM, FEMORAL

    MDR report key: 681003 · Received February 27, 2006

    Report

    Report Number
    2020394-2006-00082
    Event Type
    Malfunction
    Date Received
    February 27, 2006
    Date of Event
    February 2, 2006
    Report Date
    February 3, 2006
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A CT SCAN PRIOR TO RETRIEVAL OOF A G2 IMPLANTED 32 DAYS PREVIOUSLY, THE FILTER WAS FOUND TO BE PERPENDICULAR TO THE VENA CAVA, APEX WAS TENTING THE RIGHT CAVA WALL AND 2 LEGS WERE IN THE LEFT COMMON ILIAC. THE FILTER WAS REMOVED SUCCESSFULLY WITH A RECOVERY CONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM, FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *