BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1033019 · Received April 22, 2008

    Report

    Report Number
    2939204-2008-00141
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 6, 2008
    Report Date
    April 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COIL PROLAPSE WAS NOT NOTED UNTIL THE FINAL ANGIOGRAM WAS TAKEN; THEREFORE, IT CANNOT BE DETERMINED WHICH COIL HAD PROLAPSED. THE MFR HAS BEEN PROVIDED WITH THE BATCH NUMBERS FOR ALL THE COILS.

    Description of Event or Problem · 1

    ANGIOGRAPHY TAKEN AFTER THE SUCCESSFUL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM NEAR THE A1-A2 JUNCTION, NOTED A SMALL LOOP FROM ONE OF THE FIVE COILS PLACED WAS PROTRUDING IN TO THE PARENT VESSEL "AT THE LEVEL OF THE LEFT A1-A2 JUNCTION". THIS DID NOT INTERFERE WITH THE BLOOD FLOW OF THE PARENT VESSEL. THE PRE AND POST PROCEDURE, PT NEUROLOGICAL ASSESSMENT SHOWED A MODIFIED RANKIN SCALE OF 2 AND A HUNT AND HESS OF II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE HCG BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR FOUR BOSTON SCIENTIFIC GDC COILS AND| EV3 ECHELON MICROCATHETER 14 45DEGREE