BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUTTING BALLOON

    MDR report key: 384384 · Received March 26, 2002

    Report

    Report Number
    2024805-2002-00009
    Event Type
    Death
    Date Received
    March 26, 2002
    Date of Event
    February 25, 2002
    Report Date
    March 25, 2002
    Manufacturer
    BSC-INTERVENTIONAL TECH
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CUTTING BALLOON WAS USED IN AN OM BRANCH CIRCUMFLEX. A PERFORATION WAS NOTED AFTER THE FIRST INFLATION. PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING BALLOON PTCA LOX BSC-INTERVENTIONAL TECH B127510 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death