BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHOCOLATE PTA BALLOON

    MDR report key: 4846832 · Received June 10, 2015

    Report

    Report Number
    4846832
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 28, 2015
    Report Date
    June 10, 2015
    Manufacturer
    TRIREME MEDICAL, INC.
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING A PTA OF A RIGHT LEG A CHOCOLATE BALLOON WAS INFLATED. AFTER INFLATION THE BALLOON WAS REMOVED AND UPON INSPECTION, THE NITINOL WIRE THAT IS USUALLY ON THE BALLOON WAS NOT PRESENT. UPON FURTHER ANGIOGRAPHY OF THE RIGHT LEG THE NITINOL WIRE WAS LOCATED IN THE STENT AND WE COULD NOT RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373509 CHOCOLATE PTA BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT TRIREME MEDICAL, INC. * F140725007

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R