BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACCESS PTA BALLOON DILATATION CATHETER

    MDR report key: 3063121 · Received February 27, 2013

    Report

    Report Number
    2020394-2013-00051
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MFR REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNK. THE DEVICE HAS NOT BEEN RETURNED FOR EVAL TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON RUPTURED DURING THE FIRST INFLATION AT 14ATM IN THE SFA. DURING RETRACTION, THE BALLOON FULLY DETACHED FROM THE CATHETER AND WAS REMOVED IN ITS ENTIRETY USING A SNARE. NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85101 VACCESS PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1