BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROCOIL 10-SYSTEM COIL

    MDR report key: 1901424 · Received October 29, 2010

    Report

    Report Number
    2032493-2010-00029
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 29, 2010
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: A VISUAL EVALUATION REVEALED THAT THE DEVICE WAS RETURNED WITH THE IMPLANT DETACHED FROM THE DELIVERY PUSHER. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. THE DELIVERY PUSHER WAS TESTED FOR ELECTRICAL RESISTANCE AND MET SPECIFICATION. THE ATTACHMENT MONOFILAMENT THAT HOLDS THE IMPLANT INTACT WITH THE DELIVERY PUSHER WAS WHITE OPAQUE. THIS APPEARANCE IS CONSISTENT WITH OVER STRETCHING. THE MATERIAL APPEARS TO HAVE BEEN UNDER STRESS PRIOR TO BREAKING. ROOT CAUSE: IT APPEARS THAT THE IMPLANT WAS EXPOSED TO A FORCE THAT EXCEEDED THE MAXIMUM TENSILE SPECIFICATION OF THE ATTACHMENT MONOFILAMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT OF AN EMBOLIZATION COIL THROUGH A MICROCATHETER INTO AN ANEURYSM, THE MICROCATHETER CAME OUT OF THE ANEURYSM. UPON RETRACTING THE DEVICE, THE COIL PREMATURELY DETACHED. AN ATTEMPT WAS MADE TO RETRIEVE THE COIL USING A GOOSE NECK SNARE SUCCESSFULLY. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROCOIL 10-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. 100510HES-V P100813

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention