BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE, GUIDE, CATHETER

    MDR report key: 16521204 · Received March 10, 2023

    Report

    Report Number
    16521204
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    September 2, 2022
    Report Date
    December 1, 2022
    Manufacturer
    COOK MEDICAL, LLC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REVIEW OF THE POST-OPERATIVE CHEST X-RAY NOTICED THAT THE GUIDEWIRE FOR THE RIGHT INTERNAL JUGULAR VEIN WAS LEFT IN THE CATHETER. A CONSULT TO INTERVENTIONAL RADIOLOGY WAS MADE AND REMOVAL OF GUIDEWIRE UNDER FLUOROSCOPIC GUIDANCE WAS PERFORMED. TOOLS: THE KIT IS COMPLEX AND HAS MANY PARTS AND STEPS. THE GUIDEWIRE CASE IS OPAQUE. THE GUIDEWIRE HAS NO OBVIOUS INDICATOR OF AN ENDING. NO FORCING FUNCTION TO REMOVE GUIDEWIRE. OUTSIDE OF THE SMALL MARKERS THERE IS NO VISUAL CUE OR TACTILE CUE TO TELL THE USER THE GUIDEWIRE HAS REACHED ITS END ADDITIONALLY THE COOK GUIDEWIRE CASE IS OPAQUE AND DOES NOT HAVE A CLEAR INDICATION OF INSERTED LENGTH. IF THE USER FORGETS TO PULL THE GUIDEWIRE ALL THE WAY THROUGH THE MIDDLE LINE, THEN THERE IS ALWAYS A RISK OF THE LINE BEING CAPPED AND FLUSHED WITHOUT THE USER IMMEDIATELY NOTICING THAT THE GUIDEWIRE WAS RETAINED. EASY TO FORGET UNNECESSARY CAPS ON EACH LINE. THE GUIDEWIRE MARKINGS ARE NOT SALIENT. THE COLOR OR SHAPE DOES NOT POP OUT. THE MARKERS ARE NOT VISIBLE DUE TO LOW CONTRAST RATIO, SMALL SIZE<1CM, AND OCCLUSION BY THE HANDS. RECOMMENDATION: HAVE AN EASY TO SEE COLORED ENDING/TIP ON GUIDEWIRE TO INDICATE END. HAVE A CLEAR GUIDEWIRE CASE TO HELP USER KNOW HOW MUCH OF THE WIRE IS REMAINING. HAVE A DESIGN THAT FORCES THE USER TO STOP AND REMOVE GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054941 WIRE, GUIDE, CATHETER DQX COOK MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 9125 DA Male