BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO BALLOON DILATION CATHETER

    MDR report key: 2142243 · Received June 23, 2011

    Report

    Report Number
    2142243
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    February 7, 2011
    Report Date
    April 20, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN WAS UTILIZING THE BALLOON FOR ANGIOPLASTY OF THE FISTULA SITE WHEN THE BALLOON FRACTURED OFF THE CATHETER INTO THE FISTULA. THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON IN IT ENTIRETY WITH A SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO BALLOON DILATION CATHETER PERIPHERAL VASCULAR CATHETER LIT BARD PERIPHERAL VASCULAR, INC. * 93GU0013

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR DIALYSIS