BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS

    MDR report key: 824112 · Received February 27, 2007

    Report

    Report Number
    824112
    Event Type
    Injury
    Date Received
    February 27, 2007
    Date of Event
    February 13, 2007
    Report Date
    February 26, 2007
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED INSERTION OF A DUAL-LUMEN PICC LINE IN THE LEFT ARM. DURING THE PROCEDURE A GUIDE WIRE WAS INSERTED BY THE DUTY NURSE INTO THE VEIN A SHORT DISTANCE, BUT FAILED TO MOVE FORWARD, AND COULD NOT BE PULLED OUT OF THE VEIN. THE RESIDENT ON DUTY STEPPED IN TO ASSIST, WITH THE MEDICAL DIR SUPERVISING. THE GUIDE WIRE DEVELOPED A LOOP THAT WAS SEEN BY FLUOROSCOPE, THEN PERFORATED THE VEIN WALL AND BECAME TRAPPED IN SUBCUTANEOUS TISSUE. AFTER CONTINUED EFFORT TO FREE THE GUIDE WIRE, THE WIRE BROKE AND WAS REMOVED. FLUOROSCOPE CONFIRMED A SMALL PIECE OF THE GUIDE WIRE AND TIP REMAINED IN THE SUBCUTANEOUS TISSUE OF THE LEFT ARM. A CUT-DOWN SURGICAL PROCEDURE WAS PERFORMED THE NEXT DAY TO REMOVE THE GUIDE WIRE PIECE AND TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIODYNAMICS 6F DUAL LUMEN PICC KIT WITH RVSE TAPER LJS ANGIODYNAMICS * 922213

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention