BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRACROSS

    MDR report key: 112134 · Received August 12, 1997

    Report

    Report Number
    2939222-1997-00010
    Event Type
    Death
    Date Received
    August 12, 1997
    Date of Event
    July 1, 1997
    Report Date
    July 17, 1997
    Manufacturer
    SCIMED, A DIV. OF BSC
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IVUS CATHETER IN MAIN STEM AND LAD BRANCHES. DOCTOR COULD NOT PUT TRANSDUCER FORWARD AND COULD NOT SEE AN IMAGE. DISSECTION OCCURRED. VESSEL CLOSED DOWN, VT ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACROSS * DQO SCIMED, A DIV. OF BSC * 6173T-1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death