BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11367432 · Received February 23, 2021

    Report

    Report Number
    3004742232-2021-00060
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    September 28, 2020
    Report Date
    February 23, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10852528005428
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PROVIDER. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE INSTRUCTIONS FOR USE STATES THAT PERFORATION IS A POSSIBLE ADVERSE EVENT WHICH CAN OCCUR WITH USE OF THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE. (B)(4).

    Description of Event or Problem · 1

    A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE WAS SELECTED FOR TREATMENT OF A DE NOVO LESION WITH SEVERE ECCENTRIC CALCIUM IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). DURING THE PROCEDURE, A PERFORATION OCCURRED. THE PHYSICIAN EXPRESSED DOUBT THAT THE WIRE BIAS OF THE OAD LED TO THE PERFORATION. A COVERED STENT WAS PLACED TO RESOLVE THE PERFORATION, AND THE PATIENT STATUS WAS SATISFACTORY FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262357 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 294195 10852528005428

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention