BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 10869181 · Received November 19, 2020

    Report

    Report Number
    3001845648-2020-00879
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    January 1, 2013
    Report Date
    October 22, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    K180868 - 510 K #. DEVICE EVALUATION: THE ENBD DEVICE OF UNKNOWN RPN AND 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 RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ENBD 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. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0099-0). ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS OR DIFFICULT PATIENT ANATOMY. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE PATIENTS INVOLVED IN THIS STUDY HAD SUSPECTED PERIHILAR CHOLANGIOCARCINOMA (OF WHICH 128 PATIENTS HAD B-C TYPE III¿IV TUMORS). IT IS POSSIBLE THAT THE PATIENT¿S TUMORS RENDERED THE ANATOMY DIFFICULT TO MANOEUVRE THE DEVICE THROUGH RESULTING IN THE INABILITY FOR THE USER TO CROSS THE STRICTURE AND PLACE THE DRAINAGE CATHETER. AS PER CLINICAL INPUT IT IS ALSO POSSIBLE THAT THE ISSUE ENCOUNTERED COULD BE RELATED TO ¿PHYSICIAN¿S EXPERIENCE OR TECHNIQUE OR INABILITY TO PASS A WIRE GUIDE¿ IT IS POSSIBLY NOT A FAULT OF THE DEVICE, HOWEVER, AS WE DO NOT HAVE THIS INFORMATION OR A DEFINITIVE ROOT CAUSE, RISK WILL BE ASSESSED FOR THE DIFFICULTY EXPERIENCED OF INSERTING THE CATHETER INTO THE BILE DUCT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT REQUIRED PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE AS A RESULT OF THE USER BEING UNABLE TO PLACE THE DRAINAGE CATHETER. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    KAWASHIMA ET AL 2013 - PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE IN 164 CONSECUTIVE PATIENTS WITH SUSPECTED PERIHILAR CHOLANGIOCARCINOMA TO ASSESS THE CLINICAL BENEFITS OF PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) IN PATIENTS WITH PERIHILAR CHOLANGIOCARCINOMA. THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ENBD (RPN UNKNOWN), ENBD-5 LIGUORY, ENBD-5 LIGUORY-RT, ENBD-7, ENBD-7 LIGUORY-C, ENBD-7-LIGUORY-RT, ENBD-7-NAG-C. 1 CASE WHERE ENBD CATHETER COULD NOT BE INSERTED INTO THE BILE DUCT REQUIRING PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE. CLINICAL INPUT RECEIVED 22-OCT-2020 CONFIRMING THAT THE HARM WOULD BE REOCCURRENCE OF PATIENT SYMPTOMS THAT WOULD REQUIRED INTERVENTION TO TREAT. ASSIGNED A SEVERITY +4 ¿HARM REQUIRING SECONDARY INTERVENTION, PROLONGED HOSPITALISATION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332306 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention