BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T- COATED HEAVY DUTY NEWTON LLT WIRE GUIDE

    MDR report key: 973465 · Received April 17, 2007

    Report

    Report Number
    1820334-2007-00090
    Event Type
    Malfunction
    Date Received
    April 17, 2007
    Date of Event
    January 9, 2007
    Report Date
    February 22, 2007
    Manufacturer
    COOK, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A HEAVY DUTY NEWTON WIRE WAS USED IN PLACEMENT OF A DAWSON-MUELLER PIGTAIL CATHETER CHEST DRAIN INTO THE RIGHT PLEURAL SPACE FOR A PT WHO HAD PLEURAL EFFUSION. USING CT GUIDANCE, AN INTRODUCER NEEDLE WAS ADVANCED INTO THE PLEURAL SPACE ON THE RIGHT. ONCE PLEURAL FLUID WAS OBTAINED, AN .035 GUIDEWIRE WAS ADVANCED INTO THE PLEURAL SPACE. A TRACK WAS DILATED WITH A 10-FRENCH DILATOR AND A 10.2 FR MULTISIDEHOLE DAWSON-MUELLER PIGTAIL CATHETER WAS THEN INSERTED OVER THE .035 GUIDE WIRE INTO THE RIGHT PLEURAL SPACE. DURING THE PROCEDURE, THE NEWTON WIRE FRAYED AND THE RADIOLOGIST WAS UNABLE TO WITHDRAW THE WIRE AFTER THE CHEST DRAIN WAS IN PLACE. HE HAD TO REMOVE THE ENTIRE SYSTEM AND CHEST TUBE WAS INSERTED SUCCESSFULLY AND WAS REMOVED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T- COATED HEAVY DUTY NEWTON LLT WIRE GUIDE DQX GUIDE WIRE DQX COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other