BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGON MEDICAL ARTERIAL LINE KIT

    MDR report key: 766196 · Received September 29, 2006

    Report

    Report Number
    1625425-2006-00010
    Event Type
    Death
    Date Received
    September 29, 2006
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DQX
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN-PROCESS AND WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    UNSTABLE PT PRESENTED TO EMERGENCY DEPT WITH A CARDIAC ARREST. THE PT ALREADY HAD ONE INTRAVENOUS (IV) LINE PLACED, AND IT WAS ELECTED TO PLACE A CENTRAL LINE AND RIGHT FEMORAL ARTERIAL LINE AS THE PT DID NOT HAVE GOOD IV ACCESS. RIGHT FEMORAL PULSE WAS PALPATED AND A NEEDLE PUNCTURED THE RIGHT FEMORAL ARTERY. THE WIRE WAS THREADED AND PHYSICIAN NOTED A DIFFICULTY THREADING. UPON PULLING THE WIRE OUT, THE WIRE BEGAN TO UNRAVEL DOWN TO THE CORE OF THE WIRE. AT THAT TIME, BOTH THE WIRE AND NEEDLE WERE REMOVED, THE WIRE EXAMINED AND IT APPEARED AS THOUGH NONE OF THE WIRE BECAME DETACHED AND WAS LEFT INSIDE. A NEW KIT WAS OPENED AND PRESSURE HELD ON THE PUNCTURE SITE TO PROVIDE HEMOSTASIS. WITH THIS NEW KIT, THERE WERE NO PROBLEMS, PHYSICIAN ABLE TO THREAD WIRE WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGON MEDICAL ARTERIAL LINE KIT GUIDEWIRE DQX ARGON MEDICAL DEVICES INC. * 99478047

    Patients

    Seq Age Sex Outcome Treatment
    1 *