BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIX ACCESS DEVICE

    MDR report key: 2226536 · Received August 22, 2011

    Report

    Report Number
    3008516478-2011-00002
    Event Type
    Injury
    Date Received
    August 22, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 22, 2011
    Manufacturer
    XLUMENA INC.
    Product Code
    GCJ
    PMA / PMN Number
    K093279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ENDOSCOPIC TRANSMURAL PANCREATIC PSEUDOCYST (PC) DRAINAGE PROCEDURE WAS UNDERTAKEN TO ACCESS AND DRAIN A PC. THE PHYSICIAN WAS USING THE DEVICE FOR THE FIRST TIME. THE PHYSICIAN ATTEMPTED TO PASS THE TROCAR INTO THE PSEUDOCYST 5 TIMES. THE NAVIX COULD NOT BE SEEN ON EUS IMMEDIATELY AFTER THE SECOND THRUST. THE SCOPE WAS IN A STRAIGHT POSITION WITH PUNCTURES LOCATED ABOUT 10 CM BELOW THE GE JUNCTION. AN 19 GA FNA NEEDLE WAS SUBSEQUENTLY USED TO ACCESS THE PC, A GUIDE WIRE WAS PLACED, AND A NEEDLE KNIFE, WITH SOME DIFFICULTY, WAS USED TO ENLARGE THE TRACT. AN AXIOS STENT WAS PLACED AND THE CASE WAS SUCCESSFULLY COMPLETED. THE PT SUFFERED A PERFORATION TO THE SUPERIOR MESENTERIC ARTERY AND THE GASTROEPIPLOIC ARTERY. THE PT WAS OPERATED ON SUCCESSFULLY. THE SURGEON NOTED THAT THE CYSTIC WALL WAS VERY HARD. THE AXIOS STENT WAS IN THE CORRECT POSITION IN THE PANCREATIC PSEUDOCYST. THE PT RECOVERED WITH NO FURTHER SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIX ACCESS DEVICE ACCESS DEVICE GCJ XLUMENA INC. NVX-10-03 FGS00018

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening NEEDLE KNIFE| AXIOS STENT| DELIVERY SYSTEM| 19 GA FNA NEEDLE| GUIDE WIRE