BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 4669310 · Received April 8, 2015

    Report

    Report Number
    3004742232-2015-00021
    Event Type
    Injury
    Date Received
    April 8, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 30, 2015
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    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 DEVICE WAS DISCARDED BY THE FACILITY; THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAD BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY AND QUALITY CONTROL REQUIREMENTS. (B)(4). DISCARDED BY FACILITY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233009 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS INCORPORATED DBEC-125 122227

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention