BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPPHIRE STANDARD EMBOLIC COIL

    MDR report key: 498640 · Received December 1, 2003

    Report

    Report Number
    2029214-2003-00043
    Event Type
    Injury
    Date Received
    December 1, 2003
    Date of Event
    October 27, 2003
    Report Date
    November 1, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS FOR EMBOLIC COILING OF A CORITID CAVERNOUS FISTULA. THERE WAS SOME FRICTION WHEN PLACING THE COILS DUE TO VESSEL TORTUOSITY. ONE COIL, AFTER A MULTIPLE MANIPULATION ATTEMPTS, DEPARATED AT THE DETACHMENT ZONE. PART OF THE COIL REMAINED IN THE PARENT VESSEL AND ATTEMPTS TO RETRIEVE THE COIL WERE UNSUCCESSFUL. FURTHER ACCESS WAS BLOCKED BY THE COIL. THE PT WAS PLACED ON ANTI-PLATELETS AND WILL HAVE FURTHER PROCEDURE TO TREAT THE CCF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPPHIRE STANDARD EMBOLIC COIL EMBOLIC COIL HCG MICRO THERAPEUTICS, INC. E-7-30-T10 78730

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention