BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPPHIRE HELIX SOFT COIL

    MDR report key: 645902 · Received November 10, 2005

    Report

    Report Number
    2029214-2005-00097
    Event Type
    Death
    Date Received
    November 10, 2005
    Date of Event
    November 1, 2005
    Report Date
    November 3, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRIOR TO THE EVENT THE PT WAS BROUGHT INTO EMERGENCY AS A RESULT OF A SUBARACHNOID HEMORRHAGE. IT WAS REPORTED DURING COILING OF AN ANEURYSM LOCATED IN THE MCA, THAT THE COIL BROKE. A PORTION OF THE COIL WAS LEFT IN THE ANEURYSM AND THE REMAINING PORTION WAS LEFT IN THE MICRO CATHETER. THE PHYSICIAN RETRIEVED THE BROKEN PORTION OF THE COIL FROM THE ANEURYSM USING SILVERSPEED GUIDEWIRE, WITHOUT INJURY. HOWEVER, THE PT CONDITION WAS NOT STABLE AT THIS TIME. THE DAY AFTER OPERATION, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPPHIRE HELIX SOFT COIL ELECTROLYTICALLY DETACHABLE COIL HCG MICRO THERAPEUTICS, INC. E-2-3-T10-SO 787125

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death