BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 6020201 · Received October 12, 2016

    Report

    Report Number
    6020201
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    June 30, 2016
    Report Date
    September 14, 2016
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ATHERECTOMY OF CORONARY, THE WIRE THAT WAS USED FOR DEVICE BROKE OFF AND REMAINED IN THE CORONARY AFTER DEVICE WAS REMOVED. PATIENT WENT TO SURGERY TO HAVE DEVICE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671326 DIAMONDBACK CORONARY CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS, INC. GWC-12325LG-FLP 10507225

    Patients

    Seq Age Sex Outcome Treatment
    1 Other