BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLOW DIRECTED BALLOON CATHETER

    MDR report key: 443091 · Received February 19, 2003

    Report

    Report Number
    1820334-2003-00020
    Event Type
    Other
    Date Received
    February 19, 2003
    Date of Event
    January 23, 2003
    Report Date
    January 24, 2003
    Manufacturer
    COOK INCORPORATED
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WAS BEING UTILIZED FOR A DIALYSIS GRAFT DECLOT PROCEDURE. THE PHYSICIAN WENT TO REMOVE THE CATHETER BY OPENING UP THE STOPCOCK TO DEFLATE THE BALLOON WHICH HAD BEEN INFLATED WITH A 50/50 MIX. THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN THEN UTILIZED A CHIBA NEEDLE TO PASS THROUGH THE PATIENT AND DEFLATE THE BALLOON. THE BALLOON WENT DOWN AND THE CATHETER WAS REMOVED WITH NO PROBLEMS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW DIRECTED BALLOON CATHETER BALLOON CATHETER LIT COOK INCORPORATED NA 1201193

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other