BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR MICRO CATHETER

    MDR report key: 499175 · Received November 26, 2003

    Report

    Report Number
    2029214-2003-00044
    Event Type
    Malfunction
    Date Received
    November 26, 2003
    Date of Event
    October 21, 2003
    Report Date
    October 27, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WAS USED FOR THE DELIVERY OF AN EMBOLIC AGENT FOR THE TREATMENT OF A BRAIN ANEURYSM. THE CATHETER WAS ENTRAPPED IN THE EMBOLIC AND SEPARATED DURING WITHDRAWAL. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REBAR MICRO CATHETER NEURO MICRO CATHETER KRA MICRO THERAPEUTICS, INC. 105-5080-153C 940084J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ONYX LIQUID EMBOLIC AGENT.