BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUTRAK 2 PTA BALLOON DILATATION CATHETER

    MDR report key: 3000121 · Received February 8, 2013

    Report

    Report Number
    2020394-2013-00029
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. 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 TIP OF THE PTA BALLOON DETACHED AS IT WAS BEING ADVANCED OVER THE GUIDE WIRE. THE TIP REMAINED ON THE WIRE AND WAS RETRIEVED WITHOUT ISSUE. THERE WAS NO PT INJURY. ANOTHER PTA WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55233 VASCUTRAK 2 PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1