BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR

    MDR report key: 32884 · Received April 25, 1996

    Report

    Report Number
    32884
    Event Type
    Death
    Date Received
    April 25, 1996
    Date of Event
    April 9, 1996
    Report Date
    April 24, 1996
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROTATIONAL CORONARY ATHERECTOMY, PT BECAME HYPOTENSIVE WITH HEART BLOCK. ADVANCED CARDIAC LIFE SUPPORT WAS INITIATED WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM MCX HEART TECHNOLOGY, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death