BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 7112775 · Received December 13, 2017

    Report

    Report Number
    3004742232-2017-00153
    Event Type
    Death
    Date Received
    December 13, 2017
    Date of Event
    November 28, 2017
    Report Date
    December 13, 2017
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD FOR THE REPORTED OAD WAS UNABLE TO BE REVIEWED, AS THE LOT NUMBER WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), IT WAS REPORTED THAT THE PATIENT EXPIRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY AND WAS TREATED WITH THE OAD USING FIVE PASSES ON LOW SPEED. THE PRESSURE OF THE PATIENT BEGAN TO DROP AND THE DEVICE WAS REMOVED FROM THE BODY. THE PATIENT ENTERED CARDIOPULMONARY ARREST AND EXPIRED DURING THE PROCEDURE. THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892630 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death