BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLOW HPC MICRO CATHETER

    MDR report key: 533996 · Received March 12, 2004

    Report

    Report Number
    2029214-2004-00010
    Event Type
    Malfunction
    Date Received
    March 12, 2004
    Date of Event
    November 12, 2003
    Report Date
    March 12, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE INJECTING EMBOLIC, CATHETER WAS RUPTURED. INITIAL REPORT FROM THE PHYSICIAN INDICATED THE CATHETER WAS NOT OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC MICRO CATHETER MICRO CATHETER KRA MICRO THERAPEUTICS, INC. 105-5065 369622

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening