BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER

    MDR report key: 433712 · Received December 18, 2002

    Report

    Report Number
    2029214-2002-00007
    Event Type
    Other
    Date Received
    December 18, 2002
    Date of Event
    June 13, 2002
    Report Date
    October 30, 2002
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE INVOLVED EMBOLIZATION OF A BRAIN AVM WITH ONYX LIQUID EMBOLIC SYSTEM. UPON COMPLETION OF THE PROCEDURE, CLINICIAN WAS NOT ABLE TO WITHDRAW THE CATHETER FROM THE ONYX CAST. THE CATHETER WAS CUT AND SECURED AT THE GROIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER PERCUTANEOUS INTRAVASCULAR CATHETER KRA MICRO THERAPEUTICS, INC. 105-5065 821604J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN