BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 12318117 · Received August 13, 2021

    Report

    Report Number
    12318117
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    May 12, 2021
    Report Date
    August 3, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850000491356
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CARDIOVASCULAR SYSTEMS INC. DIAMONBACK 360 ORBITAL ATHERECTOMY SYSTEM SEVERED THE VIPERWIRE ADVANCE® CORONARY GUIDE WIRE DURING ATHERECTOMY. AS A RESULT, THE DISTAL 20MM OF THE VIPERWIRE FRAGMENTED INTO THE DISTAL RIGHT CORONARY ARTERY. THE CLINICAL REPRESENTATIVE WAS PRESENT DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216748 DIAMONDBACK CORONARY CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 368890 10850000491356

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA