BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIVAL PTA BALLOON DILATATION CATHETER

    MDR report key: 2232954 · Received July 22, 2011

    Report

    Report Number
    2020394-2011-00169
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K052149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS DISCARDED BY THE USER FACILITY. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON DILATATION CATHETER WOULD NOT DEFLATE FOR APPROX 5 MINUTES AFTER INFLATION IN THE SFA. REPORTEDLY, THE BALLOON DEFLATED AFTER THE ENDOFLATOR WAS EXCHANGED. THE DEVICE WAS REMOVED IN ITS ENTIRETY THROUGH THE SHEATH WITHOUT INCIDENT. AFTER REMOVAL, IT WAS NOTICED THAT A PORTION OF THE BALLOON WAS SHREDDED. ANOTHER PTA BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1