BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK 360 ORBITAL ARTHERECTOMY DEVICE

    MDR report key: 1593351 · Received January 22, 2010

    Report

    Report Number
    1593351
    Event Type
    Malfunction
    Date Received
    January 22, 2010
    Date of Event
    January 18, 2010
    Report Date
    January 22, 2010
    Manufacturer
    CARDIOVASCULAR SYSTEMS INC.
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A DIAMONDBACK 2.00 ORBITAL ATHERECTOMY DEVICE WAS USED IN THE SUPERFICIAL FEMORAL ARTERY TO TREAT TWO (2) LESIONS. CALCIFIC EMBOLI WERE SEEN WITH MINIMAL FLOW TO THE DORSALIS PEDIS ARTERY VIA SUBSEQUENT ANGIOGRAM. THE ARTERY EXPLORATION EMBOLECTOMY WAS PERFORMED IN THE OR. THE SUBSEQUENT ANGIOGRAM SHOWED THERE WAS SOME DISTAL FLOW ALTHOUGH IT WAS MINIMAL INTO THE TOES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ARTHERECTOMY DEVICE * MCX CARDIOVASCULAR SYSTEMS INC. DB-SC30-200 27485
    2 DIAMONDBACK 360 ORBITAL CATHETER, ARTHERECTOMY MCX CARDIOVASCULAR SYSTEMS, INC DB-SC30-200 27485

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR