BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIX ACCESS DEVICE

    MDR report key: 2048150 · Received April 4, 2011

    Report

    Report Number
    3008516478-2011-00001
    Event Type
    Injury
    Date Received
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    XLUMENA, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K093279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT SUFFERED A PNEUMOPERITONEUM AND REQUIRED SURGERY. PNEUMOPERITONEUM IS A COMPLICATION THAT CAN RESULT FROM ENDOSCOPIC DRAINAGE OF A FLUID COLLECTION WHEN THE COLLECTION IS NOT ADHERENT TO THE BOWEL WALL. THE COLLECTION WAS SUBSEQUENTLY IDENTIFIED AS A BENIGN ANGIOFIBROMA, WHICH IS NOT AN APPROVED INDICATION FOR THE NAVIX AND A CONDITION THAT IS TREATED THROUGH SURGERY RATHER THAN ENDOSCOPIC INTERVENTION. THE PT RECOVERED WITH NO FURTHER SEQUELAE AND WAS DISCHARGED TO HOME.

    Description of Event or Problem · 1

    AN ENDOSCOPIC TRANSMURAL PANCREATIC PSEUDOCYST (PC) DRAINAGE PROCEDURE WAS UNDERTAKEN TO ACCESS AND DRAIN A PC. THE PHYSICIAN HAD EXPERIENCE USING THE DEVICE DURING TWO PREVIOUS PC CASES. IT WAS REPORTED THAT THE PT HAD AN 18 CM COLLECTION, A HISTORY OF ALCOHOL USE, PANCREATITIS, AND ACUTE ABDOMINAL PAIN. THE PRE-PROCEDURE CT SCAN SHOWED A THIN WALLED STRUCTURE. THE PHYSICIAN HAD DIFFICULTY PUNCTURING THE PC WALL; THE DEVICE TENTED THE TISSUE AND SLID OFF OF THE GI WALL. THREE ATTEMPTS AT PUNCTURE WERE MADE BEFORE ENTRY WAS ACHIEVED. THE PHYSICIAN NOTED VERY LITTLE FLUID RETURN AFTER ESTABLISHING ACCESS TO THE PC. THE PHYSICIAN WAS CONCERNED WITH THE ACCESS LOCATION, SO HE REPEATED THE NAVIX STEPS. THE PHYSICIAN REPORTED RESISTANCE WHEN TURNING THE KNOB. THE PHYSICIAN ADVANCED AND RETRACTED THE KNOB MULTIPLE TIMES AND ADD'L DEVICE MANIPULATION WAS REQUIRED. EVENTUALLY, THE KNOB JAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIX ACCESS DEVICE ACCESS DEVICE GCJ XLUMENA, INC. NVX-10-03 FGS00010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PIGTAIL STENTS