BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2

    MDR report key: 3242255 · Received July 2, 2013

    Report

    Report Number
    3242255
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    April 5, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED FOR INFERIOR VENA CAVA (IVC) FILTER REMOVAL, AS FILTER WAS NO LONGER NEEDED. SPOT FILM IMAGING OF THE FILTER SHOWED THE FILTER TO BE TILTED TO THE RIGHT, ALL 6 LEGS INTACT BUT ONE FRACTURED ARM NOTED AND WAS EMBOLIZED TO THE RIGHT LUNG. THE G2 FILTER WITH THE EXCEPTION OF THE EMBOLIZED ARM FRAGMENT WAS REMOVED WITHOUT INCIDENCE. PATIENT WAS INFORMED OF RISKS AND BENEFITS OF RETRIEVAL OF THE REMAINING FRAGMENT AND PATIENT TO CONTACT PHYSICIAN REGARDING DECISION ABOUT REMOVAL/OR NOT OF FRACTURED ARM.INITIALLY, THE PATIENT WANTED TO THINK ABOUT HAVING THE FRAGMENT REMOVED, BUT THIS WAS NOT ABLE TO BE ACCOMPLISHED DUE TO FRAGMENT EMBOLIZED TO RIGHT CHEST, DUE TO EXTRAVASCULAR LOCATION OF FRAGMENT IN PERIPHERAL PORTION OF RIGHT LUNG. FRAGMENT LEFT IN PLACE AS THIS WAS THOUGHT LESS RISKY THAN HAVING AN OPEN SURGICAL PROCEDURE TO REMOVE FRAGMENT. PATIENT WAS COUNSELED BY PHYSICIAN. PATIENT IS DOING WELL AT THIS TIME, NO COMPLICATIONS AT THIS TIME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REMOVAL OF ENTIRE IVC FILTER.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301797 G2 FILTER DTK BARD PERIPHERAL VASCULAR, INC. G2 FILTER *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR