BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART ROTO BLADE

    MDR report key: 82832 · Received April 10, 1997

    Report

    Report Number
    MW1011119
    Event Type
    Injury
    Date Received
    April 10, 1997
    Date of Event
    March 26, 1997
    Report Date
    March 27, 1997
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    MCX
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PTCA, STENT AND ARTHERECTOMY OF LAD, A 1CM PIECE OF BLADE WIRE BROKE OFF AND LODGED IN THE DISTAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART ROTO BLADE ARTHERECTOMY CATHETER MCX HEART TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization