BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7F MICRO INTRODUCER SET

    MDR report key: 4208698 · Received October 23, 2014

    Report

    Report Number
    1625425-2014-00034
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 14, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DRE
    PMA / PMN Number
    K980226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISCREPANCIES WERE NOTED IN THE DEVICE HISTORY RECORD FOR THIS LOT. THERE WERE NO OTHER PRIOR SIMILAR INCIDENTS REPORTED FOR THIS LOT. NO PRODUCT FROM THE COMPLAINT LOT NUMBER REMAINED IN STOCK FOR EXAMINATION. THE COMPLAINT RETURNED DEVICE WAS OBSERVED UNDER LIGHTED MAGNIFICATION AND IT WAS OBSERVED THAT THE GUIDEWIRE WAS UNRAVELED. THE CORE WIRE WAS BROKEN AND IT APPEARED THAT THE METAL WAS STRETCHED ON THE END FROM POSSIBLY BEING PULLED. A SMALL PIECE WHICH WAS SAID TO HAVE BEEN TAKEN FROM THE PATIENT WAS APPROXIMATELY .35MM IN LENGTH. THE TIP WAS KINKED UP AND WHEN PULLED THE CORE WIRE PULLED THE COILS PROXIMALLY WHICH MADE THEM BUNCH UP. THE CONCLUSION WAS THAT THE CORE WIRE WAS PROBABLY PULLED FORCEFULLY THROUGH THE NEEDLE AND PUT UNDER UNDUE STRESS WHICH CAUSED IT TO BREAK LOOSE.

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING AN RFA. HE ACCESSED THE VEIN USING THE ACCESS NEEDLE FROM OUR PACK. ONCE THE NEEDLE WAS IN THE VEIN, HE THEN INSERTED THE GUIDE WIRE THROUGH THE NEEDLE INTO THE SSV. THE DOCTOR WAS UNABLE TO FULLY ADVANCE THE WIRE AS THE VEIN BECAME TORTUOUS. THE DOCTOR TRIED TO PULL BACK ON THE WIRE WHEN HE HEARD A POP SOUND. ONCE THE WIRE WAS PULLED OUT OF THE LEG, THE WIRE HAS PARTIALLY UNWOUND ITSELF AND PART OF THE WIRE WAS STUCK INSIDE THE PATIENTS LEG. THE ULTRASOUND TECHNICIAN WAS ABLE TO IDENTIFY WHERE THE REMAINING WIRE WAS AND THE DOCTOR HAD TO USE A HEMOSTAT TO RETRIEVE FROM THE PATIENTS LEG. THEY SUCCESSFULLY DID THIS AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677553 7F MICRO INTRODUCER SET DRE ARGON MEDICAL DEVICES INC. 11070716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention