BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO DETACHABLE COIL SYSTEM

    MDR report key: 5090455 · Received September 21, 2015

    Report

    Report Number
    5090455
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    August 26, 2015
    Report Date
    September 10, 2015
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A COIL AND HAVE IT DEPLOY THROUGH THE MICRO CATHETER. THE COIL WOULD NOT COME OUT OF ITS HOUSING. THE PATIENT WAS NOT HARMED. ANOTHER DEVICE OBTAINED AND PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623124 CONCERTO DETACHABLE COIL SYSTEM DEVICE, NEUROVASCULAR EMBOLIZATION HCG MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR A120378

    Patients

    Seq Age Sex Outcome Treatment
    1