BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 4286067 · Received November 17, 2014

    Report

    Report Number
    4286067
    Event Type
    Malfunction
    Date Received
    November 17, 2014
    Date of Event
    November 8, 2014
    Report Date
    November 17, 2014
    Manufacturer
    MICRO THERAPEUTICS, INC
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMBOLIZATION COIL FAILED TO DEPLOY. IT WAS BINDING IN THE DELIVERY CATHETER. NO PATIENT HARM OCCURRED. ANOTHER DEVICE OBTAINED AND PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741087 CONCERTO DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC * 9954984

    Patients

    Seq Age Sex Outcome Treatment
    1 *