BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROCOIL 14-SYSTEM COIL (HES)

    MDR report key: 1251923 · Received November 19, 2008

    Report

    Report Number
    2032493-2008-00030
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 21, 2008
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: THE IMPLANT WAS RETURNED DETACHED FROM PUSHER. THE COIL IS STRETCHED. THE ATTACHMENT TETHER THAT HOLDS THE IMPLANT INTACT WITH THE PUSHER IS WHITE OPAQUE. THIS APPEARANCE IS CONSISTENT WITH BEING STRETCHED. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THIS COMPLAINT IS THAT THE ATTACHMENT TETHER WAS EXPOSED TO A FORCE GREATER THAN THE MAXIMUM TENSILE SPEC OF THE ATTACHMENT MONOFILAMENT (TETHER). IT IS UNK IF THE MICROCATHETER USED WITH THIS DEVICE HAD DAMAGE THAT ATTRIBUTED TO THIS INCIDENT AS IT WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF THE EMBOLIZATION COIL, THE COIL PREMATURELY DETACHED, PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE ICA. THE COIL WAS RETRIEVED USING A GOOSENECK SNARE. THERE WAS NO CLINICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROCOIL 14-SYSTEM COIL (HES) EMBOLIZATION COIL HCG MICROVENTION, INC. 140510HES-V P0806123

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention