BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAPPHIRE TENSION SAFE COIL

    MDR report key: 516839 · Received March 11, 2004

    Report

    Report Number
    2029214-2004-00015
    Event Type
    Other
    Date Received
    March 11, 2004
    Date of Event
    February 6, 2004
    Report Date
    March 10, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COIL FRICTION ENCOUNTERED WHILE ATTEMPTING TO PLACE COILS. PER DOCTOR'S INITIAL REPORT, THE FRICTION ENCOUNTERED WHILE ATTEMTPING TO PASS THREE COILS ADDED 1-1/2 HOURS TO THE PROCEDURE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPPHIRE TENSION SAFE COIL DETACHABLE COIL HCG MICRO THERAPEUTICS, INC. E-3-8-T10-TS 415128

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other