BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET ULTRA 5000A

    MDR report key: 9218404 · Received October 22, 2019

    Report

    Report Number
    2134265-2019-12729
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    September 30, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729890584
    PMA / PMN Number
    P980037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPARK ON THE POWER CORD OCCURRED. AN ANGIOJET CONSOLE WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE WAS PLUGGED INTO THE SOCKET, THE POWER CORD SPARKED. A MARK WAS NOTED ON THE CORD. THE POWER CORD WAS TESTED AND IT ONLY RECEIVED HALF AN OMH. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013842 ANGIOJET ULTRA 5000A CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 45038 OEMTRACE 08714729890584

    Patients

    Seq Age Sex Outcome Treatment
    1