BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PTA BALLOON DILATATION CATHETER

    MDR report key: 3040611 · Received March 14, 2013

    Report

    Report Number
    2020394-2013-00068
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K052236
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON TORE AS IT WAS BEING WITHDRAWN THROUGH THE INTRODUCER SHEATH. THE SHEATH AND BALLOON WERE REMOVED SIMULTANEOUSLY WITHOUT FURTHER INCIDENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108184 ATLAS PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFWG0215

    Patients

    Seq Age Sex Outcome Treatment
    1