BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIX ACCESS DEVICE

    MDR report key: 3179860 · Received May 16, 2013

    Report

    Report Number
    3008516478-2013-00001
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    April 5, 2013
    Report Date
    May 16, 2013
    Manufacturer
    XLUMENA INC.
    Product Code
    GCJ
    PMA / PMN Number
    K093279
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT ((B)(6) MALE) UNDERWENT PANCREATIC PSEUDOCYST DRAINAGE. ACCESS OF THE TARGET STRUCTURE WAS PERFORMED WITH A NAVIX ACCESS DEVICE. AFTER THE TROCAR PUNCTURE AND CATHETER ADVANCEMENT INTO THE PSEUDOCYST FOR GUIDEWIRE PLACEMENT, THE DEVICE WAS REMOVED. DURING DEVICE REMOVAL, THE BALLOON-BEARING TIP OF THE DEVICE DISCONNECTED. THE NURSE NOTED THE TIP WAS MISSING AFTER REMOVAL. THE CATHETER TIP REMAINED IN THE TARGET STRICTURE. THE PHYSICIAN REPORTED USING A TRANSDUODENAL APPROACH (A MORE TORTUOUS APPROACH). OTHERWISE, NOTHING UNUSUAL WAS NOTED ABOUT THIS CASE, I.E., NO PROBLEM ENTERING THE CYST OVER THE TROCAR, OR PROBLEM REMOVING THE NAVIX CATHETER OVER WIRE. ON X-RAY, THE TIP WITH TWO RADIOPAQUE MARKERS WAS SEEN INSIDE THE CYST. NO ATTEMPT WAS MADE TO REMOVE THE CATHETER TIP, DUE TO RISK OF LEAK (CYST WAS POORLY ADHERENT). A WALLFLEX STENT WAS PLACED IN THE CYSTGASTROSTOMY. PT WAS TRANSFERRED BACK TO AN OUTSIDE HOSPITAL THE SAME DAY AS THE PROCEDURE. CATHETER TIP REMOVAL WAS PLANNED IN 2 WEEKS. PT RETURNED ON POD 18 FOR SUCCESSFUL REMOVAL OF CATHETER TIP AND DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219031 NAVIX ACCESS DEVICE ACCESS DEVICE GCJ XLUMENA INC. NVX-10-03 FGS00086

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other