BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUGLIELMI DETACHABLE COIL (GDC)

    MDR report key: 2090397 · Received May 16, 2011

    Report

    Report Number
    2939204-2011-00262
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE LABELING FOUND THAT THROMBOSIS IS NOTED AS AN ANTICIPATED PROCEDURAL COMPLICATION ASSOCIATED WITH SUCH PROCEDURES IN THE DIRECTIONS FOR USE. BASED ON THE INFORMATION PROVIDED THE THROMBUS WAS CAUSED BY THE MIGRATION OF THE BROKEN PIECE OF DELIVERY WIRE INTO THE BASILAR ARTERY. THE EXACT CAUSE OF THE DELIVERY WIRE BREAK CANNOT BE DETERMINED BUT FROM THE INFORMATION PROVIDED IT IS MOST LIKELY RELATED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL DETACHED FROM THE DEVICE BROKE AND MIGRATED IN THE BASILAR ARTERY DURING THE PROCEDURE. THIS RESULTED IN THROMBUS FORMATION THAT WAS TREATED WITH AGRASTAT, DOSE UNKNOWN. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL DETACHED FROM THE DEVICE BROKE AND MIGRATED IN THE BASILAR ARTERY DURING THE PROCEDURE. THIS RESULTED IN THROMBUS FORMATION THAT WAS TREATED WITH AGGRASTAT, DOSE UNKNOWN. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUGLIELMI DETACHABLE COIL (GDC) DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M00334051040 14010932

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INZONE DETACHMENT SYSTEM (BOSTON SCIENTIFIC)