BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PGLA HELICAL DETACHABLE COIL

    MDR report key: 3019823 · Received March 25, 2013

    Report

    Report Number
    2029214-2013-00272
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 24, 2013
    Report Date
    February 25, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT HAVE NOT BEEN RETURNED FOR EVALUATION.THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS:MODEL: PC-2-8-HELIX / LOT: 9460699 / DOM: 06/29/2011 / EXP: 06/28/2014.MODEL: PC-2-6-HELIX / LOT: 9631665 / DOM: 08/23/2012 / EXP: 08/16/2015.(B)(4).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING COIL WAS RETURNED FOR EVALUATION: MODEL: PC-2-6-HELIX / LOT: 9631665 / DOM: 08/23/2012 / EXP: 08/16/2015. THE COIL WAS FOUND TO BE STUCK INSIDE THE CATHETER; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THREE IMPLANT COILS COULD NOT BE DETACHED.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122877 AXIUM PGLA HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR PC-2-6-HELIX 9688669

    Patients

    Seq Age Sex Outcome Treatment
    1