BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 2983273 · Received February 1, 2013

    Report

    Report Number
    2020394-2013-00023
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE SAMPLE HAS BEEN RETURNED TO THE MFR FOR EVAL. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IN THE SFA, THE PTA BALLOON GOT STUCK IN A STENT AFTER POST-DILATION. AFTER MULTIPLE ATTEMPTS, THE PTA DEVICE WAS SUCCESSFULLY REMOVED. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45408 DORADO PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93HW0128

    Patients

    Seq Age Sex Outcome Treatment
    1