BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO BILIARY STENT

    MDR report key: 3141869 · Received May 21, 2013

    Report

    Report Number
    3141869
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 21, 2013
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    WHEN STENT WAS INSERTED INTO THE SHEATH, THE STENT CAME OFF THE STENT BALLOON. SURGEON ATTEMPTED TO REMOUNT STENT ONTO BALLOON; HOWEVER, IT WOULD NOT STAY ON. SURGEON THEN INCREASED INFLATION BALLOON AND WAS ABLE TO REMOVE STENT. SURGEON THEN USED ANOTHER BALLOON SET UP TO INSERT STENT TO APPROPRIATE SITE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MAINTAIN DILATION OF VESSEL.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225405 VALEO BILIARY STENT CATHETER, BILIARY, DIAGNOSTIC FGE C.R. BARD, INC. EV08181CD GFWA3745

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR