BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEENEN PANCREATIC STENT SET

    MDR report key: 4855778 · Received June 17, 2015

    Report

    Report Number
    4855778
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 26, 2015
    Report Date
    June 17, 2015
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    AS STENT WAS BEING REMOVED, IT BROKE IN SEVERAL PIECES. ALL PIECES RETRIEVED. PATIENT WITH HISTORY OF CHRONIC CALCIFIC PANCREATITIS, ACQUIRED PANCREATIC DIVISUM STATUS-POST EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) WHO PRESENTS TO THE ENDOSCOPY SUITE FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH REMOVAL OF STONE DEBRIS FROM THE PANCREATIC DUCT. PROCEDURAL NOTE: THE DUODENOSCOPE WAS INSERTED AND ADVANCED INTO THE SMALL BOWEL WHERE THE END OF TWO STENTS WERE SEEN EMANATING FROM THE DUCT OF SANTORINI.A HEMOCLIP WAS NOTED BELOW THE MAJOR PAPILLA. THE SPHINCTEROTOME PRELOADED WITH A GUIDEWIRE WAS THEN USED TO CANNULATE THE CBD. CONTRAST INJECTED DEFINES THE COMMON BILE DUCT(CBD). ATTEMPTS AT CANNULATING THE DUCT OF WIRSUNG WITH A SPHINCTEROTOME AND THE GUIDEWIRE WERE NOT SUCCESSFUL. THE DUODENOSCOPE WAS PLACED IN LONG POSITION IN FACING THE MINOR PAPILLA. THE DISTAL END OF THE FIRST STENT WAS GRASPED WITH A RAT TOOTH FORCEPS AND REMOVED THROUGH THE ACCESSORY CHANNEL OF THE DUODENOSCOPE. THE DISTAL END OF THE SECOND STENT WAS GRASPED WITH A RAT TOOTH FORCEPS AND BROKE AND MIGRATED PROXIMALLY INTO THE PANCREATIC DUCT. A SIDE BITE FORCEPS WAS THEN USED TO GRASP THE DISTAL END OF THE STENT WITHIN THE PANCREATIC DUCT AND REMOVED THROUGH THE ACCESSORY CHANNEL OF THE DUODENOSCOPE. 1) STENT SET GEENEN PANCREATIC GEPD-5-10 G27150 WILSON COOK - SO, LOT # C990398 2) STENT SET GEENEN PANCREATIC GEPD-5-12 G22189 WILSON COOK - SO, LOT # C1069591.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392605 GEENEN PANCREATIC STENT SET CATHETER, BILIARY, DIAGNOSTIC FGE WILSON-COOK MEDICAL, INC. * C1069591

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR YES. DUODENSOSCOPE, SPHINCTEROTOME AND GUIDEWIRE,| RAT TOOTH ENDOSCOPIC FORCEP.