BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROCOIL 14-SYSTEM COIL (HES)

    MDR report key: 1241250 · Received November 10, 2008

    Report

    Report Number
    2032493-2008-00026
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 14, 2008
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: THE IMPLANT IS RETURNED DETACHED FROM THE PUSHER. THE ATTACHMENT TETHER THAT HOLDS THE IMPLANT INTACT WITH THE PUSHER IS VISIBLE WITHIN THE PUSHER INNER DIAMETER. THE TETHER END IS WHITE/OPAQUE, CONSISTENT WITH BEING STRETCHED. THE MICROCATHETER AND IMPLANT ARE NOT AVAILABLE FOR ANALYSIS. ROOT CAUSE ANALYSIS: IT APPEARS THAT THIS DEVICE WAS EXPOSED TO A RETRACTION FORCE THAT EXCEEDED THE MAXIMUM TENSILE SPECIFICATION OF THE ATTACHMENT TETHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING POSITIONING, THE EMBOLIZATION COIL BECAME STUCK IN THE MICROCATHETER WHILE PARTIALLY IN THE ANEURYSM. THE COIL COULD NOT BE ADVANCED OR RETRACTED. THE DEVICE WAS PULLED PROXIMALLY SEPARATING THE DELIVERY PUSHER FROM THE COIL. THE COIL DETACHED WITHIN THE MICROCATHETER. THE COIL WAS RETRIEVED USING A MICROVENA SNARE. THERE WAS NO CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROCOIL 14-SYSTEM COIL (HES) EMBOLIZATION COIL HCG MICROVENTION, INC. 140820HES-V P0801233

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention