BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLOWRIDER FLOW DIRECTED MICRO CATHETER

    MDR report key: 307070 · Received December 1, 2000

    Report

    Report Number
    2029214-2000-00004
    Event Type
    Other
    Date Received
    December 1, 2000
    Date of Event
    October 18, 2000
    Report Date
    October 30, 2000
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    DYG
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MICRO CATHETER WAS USED DURING AN AVM EMBOLIZATION PROCEDURE TO DELIVER A LIQUID EMBOLIC AGENT. AFTER WAITING APPROXIMATELY 4 MINUTES, THE PHYSICIAN "GAVE ANOTHER PUSH". THERE WAS SOME RESISTANCE TO THE PUSH, AND THE CATHETER TIP APPEARED TO MOVE FORWARD. THE MARKER BAND THEN APPEARED TO TWIST. THE CATHETER WAS DIFFICULT TO REMOVE, AND THE MARKER BAND CAME OUT OF THE CATHETER AND REMAINED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOWRIDER FLOW DIRECTED MICRO CATHETER PERCUTANEOUS INTRAVASCULAR CATHETER DYG MICRO THERAPEUTICS, INC. 105-5063 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN