BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEENEN PANCREATIC STENT SET

    MDR report key: 2231081 · Received August 26, 2011

    Report

    Report Number
    3001845648-2011-00025
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 1, 2011
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. AS THE LOT NUMBER WAS NOT PROVIDED; IT WAS THEREFORE NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBER IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE TO BE RETURNED FOR EVAL; THEREFORE THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IT IS MOST LIKELY THAT THE STENT MAY HAVE MIGRATED DUE TO THE STENT BEING INSERTED THE WRONG WAY. HOWEVER, AS THE CONDITIONS OF DEVICE USAGE CANNOT BE REPLICATED, THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. PRIOR TO DISTRIBUTION, GEENEN PANCREATIC STENTS ARE SUBJECTED TO VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE (B)(4) DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE REVIEWED AS THE LOT NUMBER COULD NOT BE PROVIDED. (B)(4) DEVICES ARE USED TO DRAIN OBSTRUCTED PANCREATIC DUCTS. ACCORDING TO THE INSTRUCTIONS FOR USE, THE POTENTIAL COMPLICATIONS SECTION STATES THE FOLLOWING "THOSE ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. THOSE ASSOCIATED WITH PANCREATIC STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE PANCREATIC TRACT OR DUODENUM, STENT MIGRATION". THE PRECAUTION SECTION OF THE IFU STATES THAT "THE TAPERED TIP END OF THE STENT" MUST BE POSITIONED IN THE PANCREATIC DUCT WHILE OTHER AND REMAINS IN THE DUODENUM. IT MAY BE NOTED THAT IN THE CASE THE INCORRECT OF THE STENT WAS PLACED FIRST. THE END WITH THE 'FLAPS' WAS PLACED FIRST. IT MAY BE NOTED THAT THE GPDS DEVICES HAVE PROXIMAL FLAPS ONLY (DESIGNED TO MINIMIZE INWARD MIGRATION). MIGRATION OF PANCREATIC STENTS IS A KNOWN POTENTIAL COMPLICATION IS A KNOWN POTENTIAL COMPLICATION OF ERCP. IT MAY ALSO BE NOTED THAT IN THIS PARTICULAR CASE THAT THE POSITION OF THE STENT AND DRAINAGE WAS NOT VERIFIED WITH ENDOSCOPIC/FLUOROSCOPIC VIEWING AS PER THE INSTRUCTIONS FOR USE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE COMPLAINT COULD NOT BE VERIFIED AS THE DEVICE WAS NOT AVAILABLE FOR EVAL AS IT REMAINS IN THE PT. THIS COMPLAINT REPRESENTS AN ISOLATED OCCURRENCE FOR THIS ISSUE, FOR THIS PRODUCT OVER A 2 YEAR TIME FRAME. HOWEVER, COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    PANCREATIC STENT PLACEMENT WAS PERFORMED ENDOSCOPICALLY ON (B)(6) 2011 USING (B)(4). THE STENT WAS INSERTED OVER A WIRE GUIDE PLACED IN PANCREATIC DUCT. AT THAT TIME THE WRONG SIDE OF THE STENT (FLAPPED SIDE) WAS INSERTED INTO PANCREATIC DUCT UNINTENTIONALLY. STENT WAS PLACED WRONG WAY AROUND -FLAPPED SIDE INSERTED FIRST INSTEAD OF TAPERED END. IT WAS OBSERVED THE STENT WAS MIGRATED ON (B)(6) 2011. ON (B)(6) 2011 STENT RETRIEVAL WAS PERFORMED. A COOK 0.021" WIRE GUIDE WAS ADVANCED INTO THE INSIDE OF THE PANCREATIC STENT VIA PAPILLA. THEN A SOEHENDRA STENT RETRIEVER WAS INSERTED OVER THE WIRE GUIDE, BUT IT WOULD NOT ADVANCE. THE PHYSICIAN NOTICED THE INNER LUMEN OF THE STENT RETRIEVER WAS SQUASHED AT 3CM FROM THE TIP. ANOTHER STENT RETRIEVER WAS USED AS A REPLACEMENT TO RETRIEVE THE (B)(4) MIGRATED STENT. HOWEVER, THE PHYSICIAN WAS NOT ABLE TO REMOVE THE STENT FROM THE PT. THE STENT STILL REMAINS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEENEN PANCREATIC STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R