BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4FX50CM SGL PRO PICC CT

    MDR report key: 1860336 · Received September 24, 2010

    Report

    Report Number
    2518902-2010-00066
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 22, 2010
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECORD REVIEW, DIMENSIONAL MEASUREMENTS. ONE GUIDEWIRE AND ONE INTRODUCER WERE RETURNED FOR EVALUATION. A VISUAL EXAMINATION OF THE WIRE REVEALED THAT THE COILED TIP IS UNRAVELED. THE UNDAMAGED SECTION OF THE WIRE WAS MEASURED AND FOUND TO CONFORM TO THE DIMENSIONAL SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS WHICH MAY HAVE CONTRIBUTED TO THIS EVENT; HOWEVER, IT APPEARS THAT THE DEVICE WAS STRESSED BEYOND ITS DESIGN CAPABILITIES. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING, "DO NOT ADVANCE THE GUIDEWIRE OR CATHETER IF UNUSUAL RESISTANCE IS ENCOUNTERED. DO NOT INSERT OR WITHDRAW THE GUIDEWIRE FORCIBLY FROM ANY COMPONENT. THE WIRE MAY BREAK OR UNRAVEL. IF THE GUIDEWIRE BECOMES DAMAGED, THE INTRODUCER NEEDLE OR SHEATH/DILATOR AND GUIDEWIRE MUST BE REMOVED TOGETHER."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN INSERTING THE WIRE, THE WIRE BECAME TRAPPED IN THE VESSEL. THE DOCTOR TRIED TO RETRACT IT WITHOUT SUCCESS. AFTER DIFFERENT ATTEMPTS, HE WAS ABLE TO EXTRACT IT WITH THE HELP OF A MICROSTICK PEEL AWAY. WHEN INSPECTING THE GUIDEWIRE TIP, IT APPEARED FRAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4FX50CM SGL PRO PICC CT CT INJECTABLE PICC LJS MEDCOMP MR17034105 MAZM230

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention