BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTOBLATOR

    MDR report key: 17725 · Received July 29, 1994

    Report

    Report Number
    17725
    Event Type
    Injury
    Date Received
    July 29, 1994
    Date of Event
    February 21, 1994
    Report Date
    May 16, 1994
    Manufacturer
    HEART TECHNOLOGY INC.
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN CATHETERIZATION LAB UNDERGOING MECHANICAL ROTARY ATHERETOMY (MRA). UPON ACTIVATION OF THE MRA THE ROTOBLATOR GUIDE WIRE WAS SHEERED OFF. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE SHEARED PIECE OF GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTOBLATOR MECHANICAL ROTARY ATHERECTOMY DEVICE HEART TECHNOLOGY INC. ROTOBLATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention