BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PLATINUM HELICAL DETACHABLE COIL

    MDR report key: 3970365 · Received July 31, 2014

    Report

    Report Number
    2029214-2014-00439
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSHER ASSEMBLY WAS RETURNED WITHOUT THE IMPLANT COIL AS IT WAS DISCARDED. THE PUSHER ASSEMBLY WAS FOUND BROKEN INTO THREE SEGMENTS. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT AS THE IMPLANT COIL WAS NOT RETURNED; HOWEVER, THE PUSHER ASSEMBLY WAS FOUND BROKEN WHICH LIKELY LED TO THE DETACHMENT OF THE COIL. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. ON (B)(6) 2014, THE PATIENT UNDERWENT COILING EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE IMPLANT COIL COULD NOT BE DETACHED WITH AN INSTANT DETACHER DESPITE SEVERAL ATTEMPTS BY THE PHYSICIAN. THE MANUAL METHOD (BREAKING OF THE HYPOTUBE, AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE) WAS ALSO ATTEMPTED, BUT WITHOUT SUCCESS. THE MICROCATHETER AND COIL WERE REMOVED FROM THE PATIENT. THE MICROCATHETER AND A NEW IMPLANT COIL FROM ANOTHER MANUFACTURER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448027 AXIUM PLATINUM HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-6-HELIX 9881879

    Patients

    Seq Age Sex Outcome Treatment
    1