BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3D DETACHABLE COIL

    MDR report key: 2902198 · Received January 8, 2013

    Report

    Report Number
    2029214-2013-00010
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EVALUATED AND THE PROXIMAL END OF THE PUSHWIRE WAS FOUND BENT INSIDE THE INSTANT DETACHER. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A CAVERNOUS (CAV) INTERNAL CAROTID ARTERY (ICA) ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE IMPLANT COIL WAS SUCCESSFULLY DETACHED; HOWEVER, THE PUSHER WAS STUCK IN THE INSTANT DETACHER. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8801 AXIUM 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-14-30-3D 9662047

    Patients

    Seq Age Sex Outcome Treatment
    1