BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D AND HELICAL DETACHABLE COIL

    MDR report key: 2493287 · Received March 15, 2012

    Report

    Report Number
    2029214-2012-00144
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RETURNED FOR EVALUATION AND BOTH IMPLANT COILS WERE FOUND DETACHED. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT. MODEL# AND LOT# OF OTHER COIL INVOLVED: PC-5-15-HELIX / LOT: 9052026 - DOM: 08/06/2010 - EXP: 08/01/2013. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT DURING COIL DELIVERY, RESISTANCE WAS ENCOUNTERED. UPON REMOVAL, THE COIL DETACHED INSIDE THE CATHETER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM 3-D AND HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-5-15-3D 9276451

    Patients

    Seq Age Sex Outcome Treatment
    1