BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 11154376 · Received January 12, 2021

    Report

    Report Number
    11154376
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Date of Event
    November 14, 2020
    Report Date
    January 4, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MICRO THERAPEUTICS, INC. CONCERTO DETACHABLE COIL SYSTEM FAILED TO DEPLOY. NEW DEVICE WAS OBTAINED AND THE CASE CONTINUED WITHOUT INCIDENT. THE CONCERTO COIL SYSTEM WILL BE RETURNED TO THE VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51120 CONCERTO DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. NV-2-6-HELIX A592314

    Patients

    Seq Age Sex Outcome Treatment
    1 29565 DA