BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEENEN PANCREATIC STENT SET

    MDR report key: 2912833 · Received January 8, 2013

    Report

    Report Number
    3001845648-2013-00005
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 14, 2012
    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 LOT # OF THE GPDS-5-3 (GEENEN PANCREATIC STENT) INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. THEREFORE, IT WAS NOT POSSIBLE TO CHECK IF ANY OF THE AFFECTED LOT # REMAINED IN STOCK. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE CUSTOMER'S COMPLAINT REMAINS UNCONFIRMED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE INFORMATION RECEIVED CONFIRMED THE CUSTOMER HAD THE FOLLOWING ISSUE: "(B)(6) 2012, THE STENT WAS PLACED TO PREVENT PANCREATITIS, EXPECTING THAT THE STENT WOULD BE PASSED NATURALLY. THE PHYSICIAN CONFIRMED THE POSITIONING SLEEVE REMAINED IN THE DUODENUM WITH AN ENDOSCOPE DURING THE PROCEDURE, BUT HE PUT PRIORITY TO COMPLETING THE PROCEDURE THAN RETRIEVING THE POSITIONING SLEEVE. THOUGH HE ATTEMPTED TO RETRIEVE THE POSITIONING SLEEVE AFTER THE STENT PLACEMENT, IT WAS IMPOSSIBLE. NO FURTHER TREATMENT WAS CONDUCTED SINCE IT WAS EXPECTED THAT THE SLEEVE WOULD BE PASSED NATURALLY WITH THE STOOL. HOWEVER, THE SLEEVE PERFORATED SIGMOID COLON, AND THE SLEEVE WAS RETRIEVED BY URGENT OPERATION." AS PER THE ABOVE INFORMATION THE STENT INVOLVED IN THIS COMPLAINT WAS PLACED FOR PURPOSES OF PROPHYLACTIC TREATMENT. THIS IS A REGISTERED USE OF THE DEVICE IN (B)(4). INITIAL INFORMATION RECEIVED STATED THE PATIENT INVOLVED REMAINED HOSPITALIZED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THE PATIENT SHOULD BE DISCHARGED FROM THE HOSPITAL ALREADY THOUGH IT IS NOT CONFIRMED. IT IS DIFFICULT FOR THE SALES REP TO CONTACT THE PHYSICIAN OFTEN. NO ADVERSE EFFECTS HAVE BEEN REPORTED BY THE PHYSICIAN. AS PER THE INSTRUCTIONS FOR USE (IFU) 18922/0410 FOR THIS DEVICE: "THE POSITIONING SLEEVE OF THE PIGTAIL STRAIGHTENER IS NOT INTENDED FOR USE IN THE ACCESSORY CHANNEL OF THE ENDOSCOPE." THIS COMPLAINT RELATES TO THE POSITIONING SLEEVE AND NOT THE STENT ITSELF. THE SLEEVE IS ONLY USED WHEN PLACING THE STENT THROUGH THE BIOPSY PORT OF THE SCOPE. IN THIS CASE THE USER MADE AN ERROR IN PUSHING THE POSITIONING SLEEVE INTO THE DUODENUM AND FROM THE INFORMATION RECEIVED THEY WERE NOT SUCCESSFUL IN RETRIEVING IT FROM THE PATIENT WHICH LED TO THE PROLONGED HOSPITALIZATION OF THE PATIENT. INFORMATION RECEIVED CONFIRMED THE PHYSICIAN WAS AWARE THAT THE GEENEN STENT INVOLVED IN THIS COMPLAINT WAS USED INCORRECTLY. THE PHYSICIAN ALSO PROVIDED THE FOLLOWING COMMENTS: "I DID NOT NOTICE THAT THE POSITIONING SLEEVE WENT INTO THE ENDOSCOPIC CHANNEL SINCE I WAS IN HASTE DUE TO BLEEDING BY EST." FROM THE INFORMATION PROVIDED THE CASE OF THIS COMPLAINT CAN BE DETERMINED TO BE DUE TO USER ERROR. PRIOR TO DISTRIBUTION, GEENEN PANCREATIC STENT SETS ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THE LOT # OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. THEREFORE, IT WAS NOT POSSIBLE TO CONDUCT A REVIEW OF THE ASSOCIATED MANUFACTURING RECORDS FOR THIS DEVICE. THE TWO YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND THIS COMPLAINT FOR THE ISSUE OF THE POSITIONING SLEEVE PERFORATING THE SIGMOID COLON REPRESENTS AN ISOLATED OCCURRENCE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE CAUSE OF THIS COMPLAINT WAS DETERMINED TO BE DUE TO USER ERROR.

    Description of Event or Problem · 1

    THE PHYSICIAN NOTICED THAT THE POSITIONING SLEEVE REMAINED IN THE PANCREAS DUCT AFTER THE PROCEDURE. THE STENT WAS PLACED TO PREVENT PANCREATITIS, EXPECTING THAT THE STENT WOULD BE PASSED NATURALLY. THE PHYSICIAN CONFIRMED THE POSITIONING SLEEVE REMAINED IN THE DUODENUM WITH AN ENDOSCOPE DURING THE PROCEDURE, BUT HE PUT PRIORITY TO COMPLETING THE PROCEDURE THAN RETRIEVE THE POSITIONING SLEEVE AFTER THE STENT PLACEMENT, IT WAS IMPOSSIBLE. NO FURTHER TREATMENT WAS CONDUCTED SINCE IT WAS IMPOSSIBLE. NO FURTHER TREATMENT WAS CONDUCTED SINCE IT WAS EXPECTED THAT THE SLEEVE WOULD BE PASSED NATURALLY WITH THE STOOL. HOWEVER, THE SLEEVE PERFORATED SIGMOID COLON, AND THE SLEEVE WAS RETRIEVED BY URGENT OPERATION. INITIAL INFORMATION RECEIVED STATED THE PATIENT REMAINED HOSPITALIZED. (B)(6) 2013: INFORMATION RECEIVED FROM (B)(6) STATED THAT ACCORDING TO THE SALES REP, THE PATIENT SHOULD BE DISCHARGED FROM THE HOSPITAL ALREADY THOUGH IT IS NOT CONFIRMED. IT IS DIFFICULT FOR THE SALES REP TO CONTACT THE PHYSICIAN OFTEN. NO ADVERSE EFFECTS HAVE BEEN REPORTED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10422 GEENEN PANCREATIC STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R