BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GDC-10 SOFT 2D SR COIL

    MDR report key: 1242276 · Received November 19, 2008

    Report

    Report Number
    2939204-2008-00607
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    September 20, 2008
    Report Date
    November 4, 2008
    Manufacturer
    NEUROVASCLAR DIVISION, BOSTON SCIENTIFIC CORP
    Product Code
    HCG
    PMA / PMN Number
    K031049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT. ADDITIONAL INFO WAS RECEIVED FROM THE USER FACILITY. THE PHYSICIAN DID NOT EXPERIENCE ANY ISSUES WITH THE PREPARATION, DEPLOYMENT OR DETACHMENT OF ANY OF THE COILS AND THE COILS WERE USED IN ACCORDANCE WITH THE APPROPRIATE DIRECTIONS FOR USE. THE PHYSICIAN DID NOT ALLEGE ANY MALFUNCTION OR NON CONFORMANCE AGAINST THE COILS USED.

    Description of Event or Problem · 1

    APPROX TEN DAYS AFTER THE SUCCESSFUL EMBOLIZATION OF A BASILAR-SUPERIOR CEREBELLAR ARTERY ANEURYSM, THE PT REPORTED EXPERIENCING HALLUCINATIONS AND NARROWING OF THE FIELD OF VISION. THE PT DID NOT HAVE ANY NERVE COMPRESSION, INCREASED PRESSURE IN THE EYE OR ISCHEMIA. THE PHYSICIAN NOTED THERE WERE MULTIPLE HIGH SIGNALS AROUND THE ANEURYSM ON A MAGNETIC RESONANCE IMAGING (MRI) SCAN. THE PHYSICIAN BELIEVES THAT THE VISUAL DISTURBANCES WERE AN INFLAMMATORY REACTION AFTER THE COIL EMBOLIZATION. IT IS UNK IF THE VISUAL DISTURBANCES HAVE RESOLVED OR IF THE PHYSICIAN TOOK ANY ACTION TO TREAT THE SYMPTOMS. THE PHYSICIAN REPORTED TO BE TAKING A "WAIT AND SEE APPROACH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-10 SOFT 2D SR COIL (HCG) DETACHABLE COIL HCG NEUROVASCLAR DIVISION, BOSTON SCIENTIFIC CORP 344510-SR4 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEVENTEEN MATRIX2 COILS| TEN GDC COILS (BOSTON SCIENTIFIC)| AN EXCELSIOR SL10 MICROCATHETER| AN ECHELON MICROCATHETER (EV3)