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: 1647562 · Received April 1, 2010

    Report

    Report Number
    2939204-2010-00597
    Event Type
    Injury
    Date Received
    April 1, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 9, 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

    (B) (4)

    Additional Manufacturer Narrative · 1

    PMA # OR 510 #: K031049. ANTICIPATED PROCEDURAL COMPLICATION. 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.

    Description of Event or Problem · 1

    APPROXIMATELY FIFTEEN MONTHS AFTER THE SUCCESSFUL COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CEREBRAL ARTERY ANEURYSM, THE PATIENT UNDERWENT A SECOND PROCEDURE TO TREAT A REOCCURRENCE OF THE ANEURYSM. AN ADDITIONAL FOUR COILS WERE IMPLANTED AND THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    APPROXIMATELY FIFTEEN MONTHS AFTER THE SUCCESSFUL COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CEREBRAL ARTERY ANEURYSM, THE PATIENT UNDERWENT A SECOND PROCEDURE TO TREAT A REOCCURRENCE OF THE ANEURYSM. AN ADDITIONAL FOUR COILS WERE IMPLANTED AND THERE WAS NO REPORTED 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 33 YR Required Intervention TWO (B) (4) - GDC-10 360 SOFT SR COILS| TWO (B) (4) - GDC-10 360 SR COILS| TWO (B) (4) - GDC-10 360 SOFT SR COILS| TWO (B) (4) - GDC-10 ULTRASOFT COILS| TWO (B) (4) - GDC-10 360 SOFT SR COILS| (B) (4) - GDC-10 ULTRASOFT COIL