BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 14883488 · Received July 1, 2022

    Report

    Report Number
    3001845648-2022-00385
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Report Date
    November 14, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510 K# - K171623 INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171623 DEVICE EVALUATION THE NPDS-5 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW AS THE LOT NUMBER OF THE COMPLAINT DEVICES IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL NPDS-5 DEVICES ARE SUBJECT 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. THIS COMPLAINT WAS RAISED IN THE LITERATURE ARTICLE FUKUHARA ET AL 2021 - EXTERNAL DRAINAGE OF BILE AND PANCREATIC JUICE AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR DUODENAL NEOPLASM: A FEASIBILITY STUDY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿THE NASAL BILIARY DRAINAGE SET IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER¿. IT SHOULD BE NOTED THAT THE JAPANESE INSERT STATES THE FOLLOWING: "THIS DEVICE IS USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY OR PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER." THERE IS SUFFICIENT EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. OFF LABEL USE HAS BEEN CONFIRMED FOR PLACEMENT OF ENPD FOR ANALYSIS OF THE PROPHYLACTIC EFFECT OF ENPD. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. OFF LABEL USE HAS BEEN CONFIRMED FOR PLACEMENT OF ENPD FOR ANALYSIS OF THE PROPHYLACTIC EFFECT OF ENPD. PER THE IFU ¿THE NASAL BILIARY DRAINAGE SET IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER¿. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS WHO UNDERWENT ESD FOR SDETS FROM (B)(6)2010 TO (B)(6)2020 WERE INCLUDED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    FUKUHARA ET AL 2021 - EXTERNAL DRAINAGE OF BILE AND PANCREATIC JUICE AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR DUODENAL NEOPLASM: A FEASIBILITY STUDY. THE ENBPD PROCEDURE WAS MAINLY PERFORMED USING A SIDE-VIEWING ENDOSCOPE (TJF-260V; OLYMPUS, TOKYO, JAPAN). THE SIDE-VIEWING ENDOSCOPE WAS CAREFULLY INSERTED TO AVOID INJURING THE DUODENAL WALL, ESPECIALLY WHEN GOING THROUGH THE SUPERIOR DUODENAL ANGLE (SDA) AND STRETCHING THE ENDOSCOPE. DURING ELECTIVE CHOLANGIOGRAPHY AND PANCREATOGRAPHY, AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CATHETER (0120211; MTW ENDOSKOPIE, WESEL, GERMANY) WAS THEN ADVANCED INTO THE BILIARY TREE AND MAIN PANCREATIC DUCT WITH A 0.025-INCH HYDROPHILIC GUIDE WIRE (VISIGLIDE 2¿; OLYMPUS). IF DEEP CANNULATION WAS DIFFICULT, ANOTHER 0.025-INCH HYDROPHILIC GUIDE WIRE (NAVIPRO¿; BOSTON SCIENTIFIC JAPAN, TOKYO, JAPAN) WAS APPLIED. FINALLY, A 5-FR PIGTAIL CATHETER (QUICKPLACE V¿, PBD-V813W-05; OLYMPUS) WAS INSERTED INTO THE BILIARY TREE FOR ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD), AND A 5-FR STRAIGHT CATHETER (NASAL PANCREATIC DRAINAGE SET, G21466; COOK JAPAN, TOKYO, JAPAN) WAS INSERTED INTO THE MAIN PANCREATIC DUCT FOR ENDOSCOPIC NASOPANCREATIC DRAINAGE (ENPD). THE ENBD AND ENPD CATHETERS WERE ADVANCED TOGETHER AND LEFT AT A SUITABLE POSITION. ALL OF THE PROCEDURES WERE PERFORMED BY TWO PROFICIENT ENDOSCOPISTS (S.F. AND E.I.) WHO HAD EXPERIENCE PERFORMING MORE THAN 2000 ERCP PROCEDURES. THE ENBPD TUBES WERE REMOVED AFTER CONFIRMATION OF NO LEAKAGE BY ENDOSCOPY, GASTROINTESTINAL CONTRAST RADIOGRAPHY, ORCOMPUTED TOMOGRAPHY. OFF LABEL USE HAS BEEN CONFIRMED FOR PLACEMENT OF ENPD FOR ANALYSIS OF THE PROPHYLACTIC EFFECT OF ENPD.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 14-NOV-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548329 NASAL PANCREATIC DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown