BEUDAMED
    FDA Adverse Event Other Summary report: N

    RIVAL

    MDR report key: 2489044 · Received March 7, 2012

    Report

    Report Number
    2489044
    Event Type
    Other
    Date Received
    March 7, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 6, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE DOING ANGIOPLASTY ON FISTULA, THE BALLOON BROKE. UNABLE TO RETRIEVE ALL OF BALLOON. STENTED OVER BALLOON FRAGMENT TO CONTAIN AGAINST VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIVAL BALLOON DQY BARD PERIPHERAL VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR