BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    360 DEGREE GDC-10 SOFT COIL SR

    MDR report key: 598669 · Received April 28, 2005

    Report

    Report Number
    6000078-2005-00050
    Event Type
    Malfunction
    Date Received
    April 28, 2005
    Date of Event
    March 16, 2005
    Report Date
    April 27, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE 360 GDC-10 SOFT COIL SR DETACHED WITHIN THE MICROCATHETER. ABLE TO DEPLOY THE MAIN COIL AND FINISHED THE PROCEDURE. NO COMPLICATIONS WITH THE PT WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 360 DEGREE GDC-10 SOFT COIL SR * HCG BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *