BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUTRAK 2 PTA BALLOON DILATATION CATHETER

    MDR report key: 3000105 · Received February 8, 2013

    Report

    Report Number
    2020394-2013-00030
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 5, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 WOULD NOT DEFLATE AFTER IN-STENT AFS RESTENOSIS. THE BALLOON WAS INFLATED ONE TIME TO 10 ATM. THE BALLOON WAS PUNCTURED WITH A NEEDLE STICK THROUGH THE SKIN AND REMOVED THROUGH THE SHEATH WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55188 VASCUTRAK 2 PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFWB3381

    Patients

    Seq Age Sex Outcome Treatment
    1