BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 7098974 · Received December 8, 2017

    Report

    Report Number
    7098974
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    August 9, 2017
    Report Date
    December 1, 2017
    Manufacturer
    MICRO THERAPEUTICS INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING VIR PROCEDURE THE COILS WOULD NOT ADVANCE IN THE CATHETER, TWO DIFFERENT COILS WERE ATTEMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878992 CONCERTO DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS INC. A375921

    Patients

    Seq Age Sex Outcome Treatment
    1 NO