BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 14875444 · Received June 30, 2022

    Report

    Report Number
    3004742232-2022-00149
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 30, 2022
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850000491417
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS 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. 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. CSI ID: (B)(4).

    Description of Event or Problem · 0

    DURING AN ATHERECTOMY PROCEDURE USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), THE PATIENT EXPERIENCED SLOW FLOW, NO FLOW AND ECTOPY. ALL WERE RESOLVED WITH ADMINISTRATION OF GLYCERYL TRINITRATE (GTN). FOLLOWING THE PROCEDURE, THE PATIENT REPORTED CHEST PAIN AND A SMALL BRANCH OF THE OBTUSE MARGINAL (OM) ARTERY WAS FOUND TO BE OCCLUDED. FURTHER GTN WAS ADMINISTERED, THE PATIENT WAS MONITORED AND DISCHARGED A COUPLE OF DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058936 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. C-2DB-CL125-135 377780-1 10850000491417

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention