BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIX ACCESS DEVICE

    MDR report key: 1874207 · Received October 15, 2010

    Report

    Report Number
    3008516478-2010-00001
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    XLUMENA, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K093279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN ENDOSCOPIC TRANSMURAL PANCREATIC PSEUDOCYST (PC) DRAINAGE PROCEDURE WAS UNDERTAKEN TO ACCESS AND DILATE A PC WITH A THICK FIBROTIC WALL. THIS WAS THE FIRST-TIME THE PHYSICIAN HAD USED THE DEVICE. THE DOCTOR HAD DIFFICULTY PENETRATING THE PC WALL (MULTIPLE THRUSTS OF THE TROCAR WERE ATTEMPTED) AND HAD DIFFICULTY ADVANCING THE CATHETER (REPORTEDLY THE KNOB WAS TOUGH TO TURN AND A SNAP WAS HEARD). HEMOSTATS WERE CLAMPED ONTO THE KNOB SHAFT AND THE CATHETER WAS SUCCESSFULLY ADVANCED. THE TROCAR "GARAGE" (SAFETY SHEATH) DEPLOYED PREMATURELY AND WAS MANUALLY POSITIONED TO ENCLOSE THE TROCAR TIP AFTER IT HAD BEEN REMOVED FROM THE NAVIX. ASPIRATION OF PC CONTENTS WAS UNSUCCESSFUL; HOWEVER, NOT REQUIRED PER DOCTOR. CONTRAST INJECTION WAS POOR AND RESULTED IN A BARELY ADEQUATE CYSTOGRAM. THE HEMOSTATS WERE AGAIN USED TO ROTATE THE CATHETER KNOB AND THE DILATION BALLOON WAS CORRECTLY POSITIONED/INFLATED. DILATION BALLOON DEFLATION WAS SLOW USING 1/3 STRENGTH CONTRAST. THE NAVIX WAS REMOVED. A 10X60 FULLY COVERED WALLFLEX STENT AND A 7X7 DOUBLE PIGTAIL STENT WERE PLACED. THE PROCEDURE ENDED WITHOUT INCIDENT. DURING RECOVERY, THE PT REPORTED HAVING ABDOMINAL DISCOMFORT. AN X-RAY WAS PERFORMED AND REVEALED FREE AIR IN THE PERITONEUM. THE PT REQUIRED SURGERY DUE TO A SUSPECTED PC PERFORATION. THE SURGEON NOTED THAT THE PC WAS NOT ADHERENT TO THE STOMACH WALL AT THE POINT OF ENDOSCOPIC ENTRY AND THE PERFORATION/SURGICAL TRANSFER WERE A RESULT OF THIS ANATOMICAL CONDITION. THE PT RECOVERED WITH NO FURTHER SEQUELAE AND WAS DISCHARGED TO HOME. PERFORATIONS ARE KNOWN COMPLICATIONS OF ENDOSCOPIC PSEUDOCYST DRAINAGE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIX ACCESS DEVICE ACCESS DEVICE GCJ XLUMENA, INC. NVX-10-03 523060B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 10X60 FULLY COVERED WALLFLEX| 7X7 DOUBLE PIGTAIL STENT| CONTRAST| HEMOSTATS| INFLATION DEVICE| 0.035" GUIDEWIRE