BEUDAMED
    FDA Adverse Event Death Summary report: N

    TMR HOLMIUM LASER SYSTEM

    MDR report key: 282581 · Received June 9, 2000

    Report

    Report Number
    2950727-2000-00002
    Event Type
    Death
    Date Received
    June 9, 2000
    Date of Event
    May 16, 2000
    Report Date
    June 9, 2000
    Manufacturer
    ECLIPSE SURGICAL TECHNOLOGIES
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INITIAL REPORT DATED 06/09/2000 CONTAINS THE ADVERSE EVENT INFORMATION AS WELL AS THE ENCLOSURES (OPERATIVE REPORT, LETTER FORM PHYSICIAN, HANDPIECE INSPECTION REPORT, LASER INSPECTION REPORT MAY 22, 2000 AND LASER INSPECTION REPORT APRIL 18, 2000). THERE IS NO SUPPLEMENTAL INFORMATION. THE INVESTIGATION WAS COMPLETED AT THE TIME THE INITIAL REPORT WAS FILED.

    Description of Event or Problem · 1

    THE PT, 14 YEARS POST CORONARY ARTERY BYPASS GRAFT, WITH SEVERE ANGINA WAS SCHEDULED FOR A CORONARY ARTERY BYPASS GRAFT + TRANSMYOCARDIAL REVASCULARIZATION PROCEDURE. THE PT, UNABLE TO UNDERGO THE CORONARY ARTERY BYPASS GRAFT PORTION OF THIS PROCEDURE, RECEIVED TRANSMYOCARDIAL REVASCULARIZATION 41 CHANNELS IN THE LEFT VENTRICLE. BLEEDING FROM MULTIPLE CHANNELS CONTINUED FOR HRS DESPITE VARIOUS EFFORTS BY THE PHYSICIAN TO CONTROL AND STOP THE BLEEDING. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMR HOLMIUM LASER SYSTEM HOLMIUM LASER AND HANDPIECE DELIVERY SYSTEM GEX ECLIPSE SURGICAL TECHNOLOGIES TMR2000; SOLOGRIP III NA; TA-03016

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death