BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 9260625 · Received October 31, 2019

    Report

    Report Number
    3001845648-2019-00574
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Report Date
    October 31, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K171623 THE NPDS-5 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. AS THE LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION NPDS-5 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0107-2) STATES THE FOLLOWING: ¿THE NASAL PANCREATIC DRAINAGE SET IS USED FOR TEMPORARY DRAINAGE OF THE PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER.¿ FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THIS DEVICE WAS PLACED PERCUTANEOUSLY. AS PER THE IFU THIS IS CONSIDERED OFF-LABEL USE AND HAD THE POTENTIAL TO IMPACT ON THE DEVICE FUNCTIONALITY. THE DEVICE, IN THIS INSTANCE, DID NOT FAIL. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY (POD) 40. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. - ATTACHMENT: [A ¿¿RENDEZVOUS TECHNIQUE¿¿ FOR TREATING A PANCREATIC.PDF].

    Description of Event or Problem · 0

    LITERATURE: A ¿¿RENDEZVOUS TECHNIQUE¿¿ FOR TREATING A PANCREATIC FISTULA AFTER DISTAL PANCREATECTOMY. IMAI ET AL. 2013 "WE HEREIN PRESENT A CASE OF A PANCREATIC FISTULA AFTER DP THAT WAS SUCCESSFULLY TREATED WITH PERCUTANEOUS PANCREATIC DUCT DRAINAGE, WHICH WAS PERFORMED USING A COMBINED PERCUTANEOUS AND ENDOSCOPIC APPROACH, NAMED THE ¿¿RENDEZVOUS TECHNIQUE¿¿. IN OUR CASE, WE PERFORMED DISTAL PANCREATECTOMY WITH CELIAC ARTERY RESECTION FOR A LOCALLY ADVANCED PANCREATIC BODY CANCER. ON POD 10, THE MAIN PANCREATIC DUCT WAS ENHANCED THROUGH THE DRAIN USING CONTRAST MATERIAL. A GUIDEWIRE WAS INSERTED INTO THE MAIN PANCREATIC DUCT VIA A TRANSPAPILLARY ENDOSCOPIC APPROACH, AND THE TIP OF THE GUIDEWIRE WAS PLACED THROUGH THE FISTULA OUTSIDE OF THE BODY. USING THIS GUIDEWIRE, A 5-FR CATHETER FOR ENDOSCOPIC NASOPANCREATIC DRAINAGE (ENPD) (COOK JAPAN, TOKYO, JAPAN) WAS PLACED IN THE MAIN PANCREATIC DUCT PERCUTANEOUSLY. A CT EXAMINATION ON POD 14 REVEALED A DECREASE IN THE SIZE OF THE PERIPANCREATIC SPACE, AND IMAGING STUDIES USING CONTRAST MATERIAL ON POD 22 SHOWED ALMOST COMPLETE DISAPPEARANCE OF THIS SPACE. THE MEAN OUTPUT VIA THE PERCUTANEOUS PANCREATIC DUCT DRAIN WAS 475 ML (RANGE 200¿670 ML) PER DAY AFTER THAT. THE MEAN OUTPUT VIA THE PIGTAIL DRAIN WAS 10 ML (RANGE 0¿35) PER DAY, AND THIS DRAIN WAS WITHDRAWN ON POD 27. THE MEAN OUTPUT VIA THE PERCUTANEOUS PANCREATIC DUCT DRAIN WAS STABLE AT APPROXIMATELY 477 ML AFTER WITHDRAWING THE PIGTAIL DRAIN. PERCUTANEOUS PANCREATIC DUCT DRAIN WAS WITHDRAWN ON POD 35, AND THE PATIENT WAS DISCHARGED ON POD 40." THIS FILE WAS CREATED TO CAPTURE PANCREATIC FISTULA AFTER DISTAL PANCREATECTOMY TREATED WITH PERCUTANEOUS PANCREATIC DUCT DRAIN (OFF LABEL USE).

    Additional Manufacturer Narrative · 1

    510(K) NUMBER: K171623. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    LITERATURE: A ¿¿RENDEZVOUS TECHNIQUE¿¿ FOR TREATING A PANCREATIC FISTULA AFTER DISTAL PANCREATECTOMY. IMAI ET AL. 2013. "WE HEREIN PRESENT A CASE OF A PANCREATIC FISTULA AFTER DP THAT WAS SUCCESSFULLY TREATED WITH PERCUTANEOUS PANCREATIC DUCT DRAINAGE, WHICH WAS PERFORMED USING A COMBINED PERCUTANEOUS AND ENDOSCOPIC APPROACH, NAMED THE ¿¿RENDEZVOUS TECHNIQUE¿¿. IN OUR CASE, WE PERFORMED DISTAL PANCREATECTOMY WITH CELIAC ARTERY RESECTION FOR A LOCALLY ADVANCED PANCREATIC BODY CANCER. ON POD 10, THE MAIN PANCREATIC DUCT WAS ENHANCED THROUGH THE DRAIN USING CONTRAST MATERIAL. A GUIDEWIRE WAS INSERTED INTO THE MAIN PANCREATIC DUCT VIA A TRANSPAPILLARY ENDOSCOPIC APPROACH, AND THE TIP OF THE GUIDEWIRE WAS PLACED THROUGH THE FISTULA OUTSIDE OF THE BODY. USING THIS GUIDEWIRE, A 5-FR CATHETER FOR ENDOSCOPIC NASOPANCREATIC DRAINAGE (ENPD) (COOK JAPAN, TOKYO, JAPAN) WAS PLACED IN THE MAIN PANCREATIC DUCT PERCUTANEOUSLY. A CT EXAMINATION ON POD 14 REVEALED A DECREASE IN THE SIZE OF THE PERIPANCREATIC SPACE, AND IMAGING STUDIES USING CONTRAST MATERIAL ON POD 22 SHOWED ALMOST COMPLETE DISAPPEARANCE OF THIS SPACE. THE MEAN OUTPUT VIA THE PERCUTANEOUS PANCREATIC DUCT DRAIN WAS 475 ML (RANGE 200¿670 ML) PER DAY AFTER THAT. THE MEAN OUTPUT VIA THE PIGTAIL DRAIN WAS 10 ML (RANGE 0¿35) PER DAY, AND THIS DRAIN WAS WITHDRAWN ON POD 27. THE MEAN OUTPUT VIA THE PERCUTANEOUS PANCREATIC DUCT DRAIN WAS STABLE AT APPROXIMATELY 477 ML AFTER WITHDRAWING THE PIGTAIL DRAIN. PERCUTANEOUS PANCREATIC DUCT DRAIN WAS WITHDRAWN ON POD 35, AND THE PATIENT WAS DISCHARGED ON POD 40." THIS FILE WAS CREATED TO CAPTURE PANCREATIC FISTULA AFTER DISTAL PANCREATECTOMY TREATED WITH PERCUTANEOUS PANCREATIC DUCT DRAIN (OFF LABEL USE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055357 NASAL PANCREATIC DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1