BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSI

    MDR report key: 5064113 · Received September 2, 2015

    Report

    Report Number
    MW5056030
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 2, 2015
    Manufacturer
    CARDIOVASCULAR SYSTEMS INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    0

    Narratives

    Description of Event or Problem · 1

    INTERVENTIONAL PROCEDURE ON LEFT LEG. SHEATH AND WIRE WERE INSERTED WITH NO PROBLEMS. THE ATHERECTOMY DEVICE WAS INSERTED AND THE FIRST PASS WAS SUCCESSFUL. THE SECOND PASS THEY STARTED TO ADVANCE AND DEVICE JAMMED. (B)(6) AND REP IN THE ROOM TRIED OPTIONS TO REMOVE DEVICE BUT WERE UNSUCCESSFUL. AT THIS TIME IT WAS DECIDED TO CUT THE CATHETER DEVICE TO REMOVE MOTOR ASSEMBLY AND SEND PATIENT TO THE OPERATION ROOM FOR SURGICAL REMOVAL. DIAGNOSIS OR REASON FOR USE: PVD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583265 CSI DIAMONDBACK 360 MCW CARDIOVASCULAR SYSTEMS INC. DBP-125MICRO 145 125265

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R