BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYDROCOIL (HES) 18-SYSTEM COIL

    MDR report key: 2489689 · Received March 9, 2012

    Report

    Report Number
    2032493-2012-00007
    Event Type
    Death
    Date Received
    March 9, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 9, 2012
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: THE DELIVERY PUSHER WAS RECEIVED WITH THE IMPLANT DETACHED. THE IMPLANT COIL WAS NOT INCLUDED FOR EVAL AS IT IS WITHIN THE PT. THE DELIVERY PUSHER WAS TESTED FOR ELECTRICAL CONTINUITY AND MET SPEC. THE ATTACHMENT TETHER THAT HOLDS THE IMPLANT INTACT WITH THE DELIVERY PUSHER IS BROKEN AND IS WHITE OPAQUE. THIS APPEARANCE IS CONSISTENT WITH STRETCHING. THE LEAD WIRES OF THE DELIVERY PUSHER ARE SEPARATED FROM THE CORE WIRE. THE REMAINED OF THE DELIVERY PUSHER IS NORMAL IN APPEARANCE. THE MICROCATHETER INCLUDED APPEARS NORMAL. THE V-GRIP DETACHMENT CONTROLLER USED WITH THIS DEVICE WAS NOT RETURNED FOR EVAL. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEPLOYMENT OF AN EMBOLIZATION COIL WITHIN THE VEIN OF GALEN, THE COIL DID NOT DETACH. AN ATTEMPT WAS MADE TO RETRACT AND REMOVE THE COIL HOWEVER, IT WAS ENTANGLED WITHIN THE COIL MASS. THE COIL WAS STRETCHED TO THE GROIN AND DETACHED FROM THE DELIVERY PUSHER. NO SURGICAL INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROCOIL (HES) 18-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. 181220HES-V 99110418

    Patients

    Seq Age Sex Outcome Treatment
    1 Death