BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLOW HPC MICRO CATHETER

    MDR report key: 532626 · Received March 8, 2004

    Report

    Report Number
    2029214-2004-00012
    Event Type
    Malfunction
    Date Received
    March 8, 2004
    Date of Event
    February 6, 2004
    Report Date
    March 8, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PERFORATION IN CATHETER LUMEN NOTICED 2-3 CM FROM THE DISTAL TIP OF THE CATHETER WHILE TRYING TO INJECT EMBOLIC MATERIAL INTO THE AVM NIDUS. THE CATHETER WAS REMOVED AND CASE CONTINUED SUCCESSFULLY WITH A NEW CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLOW HPC MICRO CATHETER MICRO CATHETER KRA MICRO THERAPEUTICS, INC. 105-5066 395744

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening