BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUTTING BALLOON

    MDR report key: 391995 · Received May 3, 2002

    Report

    Report Number
    2024805-2002-00010
    Event Type
    Death
    Date Received
    May 3, 2002
    Date of Event
    March 26, 2002
    Report Date
    May 1, 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

    AS REPORTED, IN AN IN-STENT RESTENOSIS CASE, IN THE DIAGONAL BRANCH OF THE LAD, THE CUTTING BALLOON WAS INFLATED TWICE, ONE DISTAL AND ONE PROXIMAL, INSIDE THE STENT AT 10 ATM. PATIENT IMMEDIATELY BEGAN TO HAVE SEVERE CHEST PAINS AND IT WAS DETERMINED THAT APPROXIMATELY 6MM PROXIMAL TO THE INFLATION SITE IN THE LEFT MAIN, THERE WAS A SEVERE DISSECTION. THE FLAP CLOSED OFF THE MAIN PATHWAYS TO THE LEFT SIDE OF THE HEART. THE PATIENT CODED 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 52 YR Death