BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPPHIRE DETACHABLE COIL, CURVED TIP

    MDR report key: 487335 · Received October 3, 2003

    Report

    Report Number
    2029214-2003-00038
    Event Type
    Injury
    Date Received
    October 3, 2003
    Date of Event
    August 27, 2003
    Report Date
    September 3, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS FOR THE EMBOLIC COILING OF A BRAIN ANEURYSM. A COIL WAS BEING PLACED TO FILL THE ANEURYSM BUT DID NOT FIT INTO THE ANEURYSM. WHEN TRYING TO RETRIEVE THE COIL, THE COIL BROKE. APPROXIMATELY 3CM OF THE COIL EXTENDED INTO THE "ARTERIA" ANTERIOR. THE PHYSICIAN WAS NOT SUCCESSFUL IN RECOVERING ALL OF THE COIL. DURING THE ATTEMPTS, THE PATIENT DEVELOPED TEMPORARY VASOSPASM. THE COIL SEGMENT REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPPHIRE DETACHABLE COIL, CURVED TIP EMBOLIC COIL HCG MICRO THERAPEUTICS, INC. E-5-25-T10-CT 320157

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention