BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUTRAK PTA BALLOON DILATATION CATHETER

    MDR report key: 2111110 · Received May 24, 2011

    Report

    Report Number
    2020394-2011-00114
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE SAMPLE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE FIRST INFLATION IN THE AREA OF THE PERONEAL-POPLITEAL ARTERIES, THE PTA BALLOON WOULD NOT DEFLATE. ATTEMPTS WERE MADE TO DEFLATE THE BALLOON WITH A SYRINGE, AND CUTTING THE INFLATION HUB, BUT THESE WERE UNSUCCESSFUL. THE BALLOON WAS PUNCTURED WITH A GUIDEWIRE AND DEFLATED. THE BALLOON WAS REMOVED THROUGH THE INTRODUCER SHEATH WITHOUT INCIDENT AND ANOTHER PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCUTRAK PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 100806-4

    Patients

    Seq Age Sex Outcome Treatment
    1