BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1694115 · Received May 19, 2010

    Report

    Report Number
    2939204-2010-00484
    Event Type
    Injury
    Date Received
    May 19, 2010
    Report Date
    October 3, 2006
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA # OR 510 #: K050700. 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. NEUROLOGICAL DEFICITS THAT CAN RESULT IN DISABILITY ARE A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE COIL EMBOLIZATION TWO RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSMS. IMMEDIATELY POST PROCEDURE THE PATIENT WAS STABLE. THE PATIENT WAS DISCHARGED WITH "MODERATE DISABLITY (INDEPENDENT)", DATE WAS NOT PROVIDED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX DETACHABLE COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK536

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Disability MATRIX COIL (BOSTON SCIENTIFIC)