BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSI OAD MODEL : DBEG - 125

    MDR report key: 5999423 · Received October 4, 2016

    Report

    Report Number
    MW5065176
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 20, 2016
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A CORONARY ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION WITH DEEP DISSECTION EXTENDING INTO THE AORTA WALL WAS OBSERVED. PT PLACED ON IABP AND SENT TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649416 CSI OAD MODEL : DBEG - 125 ATHRECTOMY CATHETER MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 162098

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention