BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PLATINUM HELICAL DETACHABLE COIL

    MDR report key: 3870673 · Received June 12, 2014

    Report

    Report Number
    2029214-2014-00339
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 15, 2014
    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 PUSHER ASSEMBLY WAS RETURNED FOR EVALUATION WITH THE IMPLANT COIL STILL ATTACHED CONTRADICTING WHAT WAS PREVIOUSLY REPORTED IN THE ORIGINAL EVENT DESCRIPTION. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE REPORTED EVENT. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. (B)(4)

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY. DURING THE PROCEDURE, IT WAS REPORTED THE IMPLANT COIL PREMATURELY DETACHED INSIDE THE CATHETER. THE DETACHED IMPLANT COIL WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH OTHER COILS (USING THE SAME CATHETER). PRIOR TO THE PROCEDURE, IT WAS REPORTED THE PUSHWIRE WAS FOUND FOLDED AS THE DEVICE WAS OPENED AND REMOVED FROM THE INNER PACKAGE. THE PHYSICIAN UNFOLDED THE PUSHWIRE AND ADVANCED THE COIL INTO THE MICROCATHETER DESPITE ITS CONDITION.NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348315 AXIUM PLATINUM HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-3-HELIX 9827041

    Patients

    Seq Age Sex Outcome Treatment
    1