BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 19225226 · Received May 1, 2024

    Report

    Report Number
    3004742232-2024-00179
    Event Type
    Injury
    Date Received
    May 1, 2024
    Date of Event
    April 16, 2024
    Report Date
    April 1, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC
    Product Code
    MCX
    UDI-DI
    10850000491554
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VIPERWIRE ADVANCE GUIDE WIRE MODEL NUMBER: GWC-12325LG-FT. VIPERWIRE ADVANCE GUIDE WIRE MFG DATE: 07/31/2023. VIPERWIRE ADVANCE GUIDE WIRE EXPIRATION DATE: 07/31/2025. VIPERWIRE ADVANCE GUIDE WIRE UDI: (B)(4). THE MATERIAL INSPECTION REPORT FOR THIS GUIDEWIRE 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 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

    FOLLOWING SIX LOW SPEED TREATMENTS AND FIVE HIGH SPEED TREATMENTS IN THE MID RIGHT CORONARY ARTERY, THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) JUMPED 2-3MM. THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WAS OBSERVED TO BE FRACTURED. THE PATIENT WAS SENT TO A PREPLANNED BYPASS SURGERY. NO INTERVENTION WAS PERFORMED TO RETRIEVE THE FRACTURED GUIDE WIRE. THE FRACTURED COMPONENT REMAINS IN PATIENT. THE PATIENT WAS STABLE. ACCORDING TO THE PHYSICIAN, THE FRACTURE WAS DUE TO POOR GUIDE SUPPORT AND WIRE BIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131625 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC DBEC-125 500931-1 10850000491554

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other VIPERWIRE ADVANCE CORONARY GW (LOT #: 499455-1)