BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUTTING BALLOON

    MDR report key: 380698 · Received March 8, 2002

    Report

    Report Number
    2024805-2002-00005
    Event Type
    Death
    Date Received
    March 8, 2002
    Date of Event
    February 4, 2002
    Report Date
    March 8, 2002
    Manufacturer
    BSC - INTERVENTIONAL TECH
    Product Code
    LOX
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN A DOUBLE WIRE PROCEDURE IN THE "LAD" THE PHYSICIAN INFLATED THE CUTTING BALLOON. THE PHYSICIAN THEN RE-INFLATED THE CUTTING BALLOON. A PERFORATION WAS NOTICED AFTER THE SECOND INFLATION. WHEN ATTEMLPTING TO REMOVE THE CUTTING BALLOON, THE DEVICE BECAME WRAPPED UP IN THE WIRES. THE DEVICES WERE REMOVED TOGETHER. THE PATIENT'S PRESSURE DROPPED, PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING BALLOON PTCA LOX BSC - INTERVENTIONAL TECH B130010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death