BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART TECHNOLOGY ROTABLATOR

    MDR report key: 19924 · Received January 31, 1995

    Report

    Report Number
    19924
    Event Type
    Death
    Date Received
    January 31, 1995
    Date of Event
    January 20, 1995
    Report Date
    January 31, 1995
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO PROCEDURE, DEVICE WAS SET UP AND TESTED BY CARDIOLOGISTS. IT CAME UP TO SPEED, AND STAFF NOTIFIED THAT IT "SOUNDED FUNNY". CARDIOLOGISTS WERE AWARE OF SOUND BUT NO PROBLEM IDENTIFIED. DEVICE WAS USED ON CASE AND DISSECTION OF LAD DEVELOPED. PT BECAME UNSTABLE AND WENT TO OR EMERGENTLY FOR CABG. PT SUBSEQUENTLY EXPIRED FROM CAD, RENAL FAILURE, ANOXIC BRAIN DAMAGE, ACUTE MI, AND CARDIAC ARREST, TWO DAYS LATER. THERE IS NO DIRECT EVIDENCE OF DEVICE MALFUNCTION, OR OF MALFUNCTION CAUSING THE DISSECTION. HOWEVER, BECAUSE OF THE SEVERE OUTCOME TO THIS PT, AND THE REPORT OF THE INSTRUMENT "SOUNDING FUNNY", HOSP FELT IT WOULD BE MOST CAUTIOUS TO REPORT THIS OCCURRENCE UNTIL IT IS SHOWN NOT TO BE A MALFUNCTION BY THE MFR. THE INSTRUMENT WAS RETURNED TO THE MFR ON 1/23/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART TECHNOLOGY ROTABLATOR CORONARY ROTABLATOR MCX HEART TECHNOLOGY, INC. 1.5MM X 135MM CORONARY 94224

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death