BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE WIRE)

    MDR report key: 11148520 · Received January 11, 2021

    Report

    Report Number
    3004742232-2021-00007
    Event Type
    Injury
    Date Received
    January 11, 2021
    Date of Event
    January 6, 2021
    Report Date
    January 11, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10852528005701
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    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 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 PRIOR TO DISTRIBUTION. CSI ID: (B)(4).

    Description of Event or Problem · 1

    TREATMENT WAS PERFORMED IN THE RIGHT CORONARY ARTERY WITH A CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). AS THE CROWN OF THE OAD WAS ADVANCED, IT CONTACTED THE RADIOPAQUE PORTION OF THE VIPERWIRE GUIDE WIRE. GUIDANCE WAS PROVIDED FROM CSI STAFF THAT THE CROWN SHOULD NOT BE OPERATED NEAR THE TIP OF THE GUIDE WIRE, HOWEVER THE ACTION WAS REPEATED AND THE GUIDE WIRE FRACTURED. THE WIRE FRAGMENT WAS SECURED TO THE VESSEL WALL WITH A STENT AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43823 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE WIRE) CORONARY ATHERECTOMY DEVICE (GUIDE WIRE) MCX CARDIOVASCULAR SYSTEMS, INC. GWC-12325LG-FT 295974 10852528005701

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention