BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO NYLON HELICAL DETACHABLE COIL

    MDR report key: 3050408 · Received April 10, 2013

    Report

    Report Number
    2029214-2013-00361
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 21, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSHWIRE WAS RETURNED FOR EVALUATION AND THE TACK WELD ON THE PUSHER ASSEMBLY WAS FOUND BROKEN. THE BROKEN TACK WELD LIKELY CAUSED THE COIL TO DETACH.(B)(4).

    Description of Event or Problem · 1

    RIGHT GASTRIC EMBOLIZATION VIA THE LEFT HEPATIC ARTERY. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SECOND IMPLANT COIL PREMATURELY DETACHED AS IT WAS BEING REPOSITIONED AND REMAINED IN THE PATIENT.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149324 CONCERTO NYLON HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR NV-3-8-HELIX 9669148

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability