BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 14446220 · Received May 19, 2022

    Report

    Report Number
    3001845648-2022-00290
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    March 10, 2016
    Report Date
    September 26, 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

    PMA/510(K) # K180868. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K180868 DEVICE EVALUATION THE ENBD-5-LIGUORY DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW AS THE LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ENBD-5-LIGUORY DEVICES ARE SUBJECT TO VISUAL 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 (IFU0129) 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¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THE JAPANESE PACKAGING INSERT (C-ES0906F05) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF THE DEVICE WAS USED OFF LABEL WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE USER INSERTED ENBD DEVICE THOUGHT THE STENT TO FACILITATE BILIARY DRAINAGE. PER THE CLINICAL INPUT THE SEPTIC SHOCK AND PANCREATICODUODENECTOMY WAS LIKELY DUE TO THE PATIENTS PRE-EXISTING CONDITION. THE ENBD DEVICE WAS PLACED AFTER ADVERSE EFFECTS OCCURRED SUGGESTING THE DEVICE WAS DID NOT CONTRIBUTE TO THE SEPSIS AND SEPTIC SHOCK. PER THE MEDICAL ADVISOR INPUT "IT WAS NOT CLEAR THE REASON THAT A NASAL BILIARY CATHETER WAS INSERTED THROUGH THE STENT TO FACILITATE BILIARY DRAINAGE, WAS IT BECAUSE THE STENT WAS OCCLUDED AND THE ENBD WAS USED AS A RESCUE DEVICE? IF SO, THE SEPTIC SHOCK WAS LIKELY DUE TO THE STENT OCCLUSION. AS PER THE FURTHER INFORMATION ABOVE, THE SEPTIC SHOCK WAS DUE TO STENT OCCLUSION SECONDARY TO A BLOOD CLOT, SO THIS SEPSIS/SEPTIC SHOCK WAS NOT RELATED TO ENBD. IT WAS NOT CLEAR IN CONTEXT THAT THE SEPTIC SHOCK OCCURRED BEFORE OR AFTER THE ENBD INSERTION; THE SEPTIC SHOCK OCCURRED PRIOR TO ENBD PLACEMENT. ENBD WAS USED TO TREAT THE SEPTIC SHOCK FROM WHICH THE PATIENT RECOVERED IN 2 DAYS. ENBD WAS IRRELEVANT TO PANCREATICODUODENECTOMY; IT WAS A CONSEQUENCE OF THE PATIENTS UNDERLYING CONDITION. THE ENBD DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE SEPTIC SHOCK " SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT RECOVERED FROM SEPTIC SHOCK IN 2 DAYS. A PANCREATICODUODENECTOMY WAS SUBSEQUENTLY PERFORMED AND BILIARY ADENOCARCINOMA WAS CONFIRMED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SHINJO, 2016, LIGUORY NASAL BILIARY DRAINAGE SET BILIARY HEMOSTASIS USING AN ENDOSCOPIC PLASTIC STENT PLACEMENT FOR UNCONTROLLED HEMOBILIA CAUSED BY TRANSPAPILLARY FORCEPS BIOPSY (WITH VIDEO). A 78-YEAR-OLD WOMAN WAS REFERRED TO OUR HOSPITAL FOR THE EXAMINATION AND TREATMENT OF JAUNDICE. COMPUTED TOMOGRAPHY (CT) SHOWED A THICK BRANCH OF THE GASTRODUODENAL ARTERY RUNNING NEAR THE BILIARY WALL. ERCP DEMONSTRATED A LONG DISTAL BILE DUCT STRICTURE A TRANSPAPILLARY FORCEPS BIOPSY (FB-39Q-1; OLYMPUS, TOKYO, JAPAN) WAS PERFORMED WITHOUT CONSIDERING THE COURSE OF THE ARTERY. IMMEDIATELY AFTER THE BIOPSY, MASSIVE BLEEDING WAS OBSERVED FROM THE ORIFICE OF THE PAPILLA. THE HEMOBILIA WAS PULSATILE AND DID NOT ATTENUATE AFTER 1 MIN; THEREFORE, AN EBPS (8.5 FR, 7 CM; TANNENBAUM; COOK, BLOOMINGTON, USA) ((B)(4)) WAS PLACED THUS, THE BLEEDING CEASED IMMEDIATELY. THE NEXT DAY, THE PATIENT EXPERIENCED HIGH FEVER AND DECREASE IN BLOOD PRESSURE AS WELL AS IMPAIRED CONSCIOUSNESS. SEPSIS (ESCHERICHIA COLI) BECAUSE OF ACUTE CHOLANGITIS WAS DIAGNOSED, ALTHOUGH THE PATIENT¿S SERUM HEMOGLOBIN LEVEL WAS WITHIN THE NORMAL RANGE. AN URGENT DUODENOSCOPY REVEALED THAT A BLOOD CLOT HAD OCCLUDED THE EBPS; A NASAL BILIARY CATHETER (5 FR, 250 CM; LIGUORY; COOK, BLOOMINGTON, USA) ((B)(4)) WAS INSERTED THROUGH THE STENT TO FACILITATE BILIARY DRAINAGE. THE PATIENT RECOVERED FROM SEPTIC SHOCK IN 2 DAYS. A PANCREATICODUODENECTOMY WAS SUBSEQUENTLY PERFORMED AND BILIARY ADENOCARCINOMA WAS CONFIRMED. WE COULD NOT CONFIRM THE BIOPSY SITE, WHICH WAS THE CAUSE OF MASSIVE HEMOBILIA, ON THE RESECTED SPECIMEN PATHOLOGICALLY. THIS FILE WILL CAPTURE OFF LABEL USE OF ENBD: INSERTED THROUGH THE STENT TO FACILITATE BILIARY DRAINAGE. THE PATIENT RECOVERED FROM SEPTIC SHOCK IN 2 DAYS. A PANCREATICODUODENECTOMY WAS SUBSEQUENTLY PERFORMED AND BILIARY ADENOCARCINOMA WAS CONFIRMED.

    Description of Event or Problem · 0

    SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION 26 - SEPT - 2022

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891934 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female