BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROCOIL EMBOLIC SYSTEM (HES)

    MDR report key: 578388 · Received March 3, 2005

    Report

    Report Number
    2032493-2005-00005
    Event Type
    Injury
    Date Received
    March 3, 2005
    Date of Event
    February 9, 2005
    Report Date
    March 1, 2005
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 7-MM BASILAR ANEYURYSM WAS FIRST TREATED WITH A MICRUS SPHERICAL FRAMING COIL. THE SECOND COIL USED WAS A MICROVENTION 5-MM X 15-CM HES -14 COIL. DURING DELIVERY OF THE HES-14 COIL, THERE WAS CONSIDEREABLE REPOSITIONING BY THE PHYSICIAN. THE COIL DETACHED PREMATURELY AND WAS REMOVED WITH A SYRINGE/VACUUM. THE PROCEDURE WAS SUCCESSFUL CONTINUED WITH THREE ADDITIONAL HES COILS. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROCOIL EMBOLIC SYSTEM (HES) EMBOLIZATION COIL HCG MICROVENTION, INC. 140515HES-R P0409396

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention