BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PTA BALLOON DILTATION CATHETER

    MDR report key: 2760641 · Received September 19, 2012

    Report

    Report Number
    2020394-2012-00210
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 14, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K052236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DURING REMOVAL OF THE PTA BALLOON DILATATION CATHETER THE BALLOON APPEARED TO HAVE UNRAVELED. THE DEVICE WAS USED FOR DILATATION OF THE LEFT BRACHIOCEPHALIC VEIN. A WALL STENT WAS PRESENT NEAR THE TREATMENT SITE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PTA BALLOON DILTATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFUJ3146

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR