BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI

    MDR report key: 1764182 · Received July 20, 2010

    Report

    Report Number
    2939204-2010-00816
    Event Type
    Injury
    Date Received
    July 20, 2010
    Date of Event
    June 9, 2010
    Report Date
    July 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE LABELING FOUND THAT THE DIRECTIONS FOR USE NOTES THAT MULTIPLE PROCEDURES MAY BE REQUIRED TO OCCLUDE AN ANEURYSM. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    PMA# OR 510# - K031049 AND K042539.

    Description of Event or Problem · 1

    AT THE 499 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A SECOND PROCEDURE TO TREAT THE ANEURYSM. DURING THIS SECOND PROCEDURE, FIVE COILS WERE IMPLANTED AND THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    AT 499 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A SECOND PROCEDURE TO TREAT THE ANEURYSM. DURING THIS SECOND PROCEDURE, FIVE COILS WERE IMPLANTED AND THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK159

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention TWO (B) (4) - GDC-10 360 SOFT COILS| (B) (4) - GDC-10 ULTRASOFT COIL| (B) (4) - GDC-10 360 COIL| TWO (B) (4) - GDC-10 ULTRASOFT COILS