BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 2935566 · Received January 30, 2013

    Report

    Report Number
    2029214-2013-00099
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 1, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND THE EVALUATION INDICATED THAT THE IMPLANT COIL DID NOT DETACH, BUT SEPARATED FROM THE DETACHMENT STICK ON THE COIL SHELL. THE CAUSE COULD NOT BE DETERMINED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT THE SIXTH COIL PREMATURELY DETACHED WHEN IT WAS INSERTED INTO THE ECHELON-10 CATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW IMPLANT COIL.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40573 AXIUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-6-3D 9649646

    Patients

    Seq Age Sex Outcome Treatment
    1