BEUDAMED
    FDA Adverse Event Death Summary report: N

    THE HEART LASER CO2 TMR SYSTEM

    MDR report key: 213084 · Received March 5, 1999

    Report

    Report Number
    1287243-1999-00001
    Event Type
    Death
    Date Received
    March 5, 1999
    Date of Event
    December 14, 1998
    Report Date
    February 4, 1999
    Manufacturer
    PLC MEDICAL SYSTEMS, INC.
    Product Code
    MNO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THEN USER REPLACED THE RIGHT ANGLE HAND PIECE THAT USER WERE USING BY THE STRAIGHT HAND PIECE AND APPLIED 3 SHOTS ON THE ANTERIOR WALL...THEN USER OBSERVED A RING OF EPICARDIAL BURN SURROUNDING THE LASER CHANNEL. THE TECHNICIANS MADE SOME ADJUSTMENTS IN THE OPTICS OF THE MACHINE. NEW SHOTS WERE APPLIED ON THE ANTERIOR AND LATERAL WALL, EVERY ONE CONFIRMED, BUT THE SAME BURN RING WAS OBSERVED. THE IMMEDIATE POSTOPERATIVE COURSE WAS UNEVENTFUL BUT ON THE 20TH HOUR THE PT DEVELOPED AN ACUTE SEVERE BLEEDING THROUGH THE THORACIC TUBE, FOLLOWED BY HYPOVOLEMIA AND CARDIAC ARREST. THE PT WAS REOPENED AND USER DISCLOSED RUPTURE OF THE LATERAL LEFT VENTRICAL FREE WALL. REPAIR WAS ATTEMPTED, BUT NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE HEART LASER CO2 TMR SYSTEM CARDIOVASCULAR SURGICAL LASER MNO PLC MEDICAL SYSTEMS, INC. HEART 08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death