BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC-18 2D COIL

    MDR report key: 1171549 · Received September 17, 2008

    Report

    Report Number
    2939204-2008-00377
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 27, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE THE PHYSICIAN WAS RE-SHEATHING THE COIL TO REPOSITION THE MICROCATHETER; THE COIL PREMATURELY DETACHED INSIDE ITS SHEATH. BOTH THE MICROCATHETER AND COIL WERE SUCCESSFULLY REMOVED WITHOUT ANY COMPLICATIONS TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-18 2D COIL (HCG) NEUROVASCULAR EMBOLIZATION COIL HCG NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP 352123-4 0011533035

    Patients

    Seq Age Sex Outcome Treatment
    1