BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROCOIL HYDROFILL 10-SYSTEM COIL

    MDR report key: 2950320 · Received February 6, 2013

    Report

    Report Number
    2032493-2013-00002
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: A VISUAL ANALYSIS OF THE DEVICE REVEALED THE COIL DETACHED FROM THE DELIVERY PUSHER. THE IMPLANT COIL IS COMPLETELY STRETCHED AT THE PROXIMAL END OVER 12.0". THE TETHER THAT ATTACHES THE IMPLANT COIL TO THE DELIVERY PUSHER WAS BROKEN. THE MOST DISTAL SEGMENT OF THE BROKEN TETHER HAS STRIATIONS PRESENT AND CHARACTERISTICS OF STRETCHING. THE REMAINDER OF THE PUSHER WAS NORMAL IN SPECIFICATION. THE ROOT CAUSE OF THIS COMPLAINT APPEARS TO BE DUE TO THE DEVICE BEING EXPOSED TO A FORCE THAT EXCEEDED THE MAXIMUM TENSILE SPECIFICATION OF THE ATTACHMENT MONOFILAMENT. THE MICROCATHETER USED WITH THIS DEVICE WAS NOT RETURNED FOR EVAL. WE CANNOT DETERMINE IF THIS WAS A CONTRIBUTING FACTOR. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON POSITIONING AN EMBOLIZATION COIL WITHIN A BIFURCATION ANEURYSM, APPROX 5CMS OF THE COIL WAS DEPLOYED WHEN A COIL LOOP CAME OUT THROUGH THE ANEURYSM WIDE NECK. THE COIL WAS RETRACTED AND IN DOING SO, IT WAS OBSERVED THERE WAS NO MOVEMENT OF THE COIL. THE COIL PREMATURELY DETACHED PARTIALLY WITHIN THE ANEURYSM AND THE MICROCATHETER. THE COIL WAS REMOVED SUCCESSFULLY USING A GOOSE NECK SNARE. NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50588 HYDROCOIL HYDROFILL 10-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. 100720HFIL-V 12090503

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention