BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C. S. I. DIAMOND BACK CORONARY CLASSIC

    MDR report key: 8582466 · Received May 3, 2019

    Report

    Report Number
    MW5086383
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 18, 2019
    Report Date
    April 26, 2019
    Manufacturer
    CSI PRODUCTS (CARDIOVASCULAR SYSTEMS) INCORPORATED
    Product Code
    MCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COMPLEX PCI OF THE RCA USING ATHERECTOMY, CSI PERFORMED FOR A SINGLE RUN. DEVICE ADVANCED THEN GOT STUCK ON THE WIRE, SHEARING IT. MULTIPLE ATTEMPTS TO RETRIEVE WIRE FAILED. DISTAL END OF WIRE RETAINED IN DISTAL RCA. PT ADMITTED AND UNDERWENT CABG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373685 C. S. I. DIAMOND BACK CORONARY CLASSIC CATHETER, CORONARY ATHERECTOMY MCX CSI PRODUCTS (CARDIOVASCULAR SYSTEMS) INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention