BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 2050525 · Received March 15, 2011

    Report

    Report Number
    2020394-2011-00047
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE SAMPLE HAS BEEN RETURNED, BUT HAS NOT BEEN EVALUATED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON RETRACTING THE PTA BALLOON THROUGH THE SHEATH AFTER TREATMENT IN THE SFA, THE BALLOON SEPARATED FROM THE CATHETER BUT DID NOT DETACH COMPLETELY. REPORTEDLY, THE BALLOON WAS ABLE TO BE REMOVED WITH THE SHEATH AND ANOTHER PTA BALLOON 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 DORADO PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93CU0052

    Patients

    Seq Age Sex Outcome Treatment
    1