BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 7024626 · Received November 13, 2017

    Report

    Report Number
    3004742232-2017-00129
    Event Type
    Death
    Date Received
    November 13, 2017
    Date of Event
    October 19, 2017
    Report Date
    November 13, 2017
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE FACILITY, THEREFORE AN ANALYSIS OF THE COMPLAINT DEVICE IS NOT POSSIBLE. THE LOT NUMBER WAS NOT RECORDED AND COULD NOT BE OBTAINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION AND PATIENT DEATH OCCURRED WHILE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AN IMPELLA VENTRICULAR ASSIST DEVICE WAS UTILIZED DURING THE PROCEDURE AND WAS INSERTED PRIOR TO ATHERECTOMY. THE OAD WAS INSERTED INTO THE PATIENT AND TWO RUNS WERE COMPLETED AT LOW SPEED. THE DEVICE WAS THEN OPERATED BACKWARD THROUGH THE LESION AT HIGH SPEED, AND MULTIPLE PERFORATIONS WERE NOTED. IT WAS REPORTED THAT THE PATIENT EXPIRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804550 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE, PRODUCT CODE: MCX MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death