BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 14852663 · Received June 29, 2022

    Report

    Report Number
    3001845648-2022-00382
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    September 4, 2014
    Report Date
    January 20, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K180868. THE INVESTIGATION IS IN PROGRESS AND A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K180868. DEVICE EVALUATION: THE LIGUORY NASAL BILIARY DRAINAGE SET DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: N/A. 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 ALL LIGUORY NASAL BILIARY DRAINAGE SET 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. THIS CASE SERIES DESCRIBES THE USE OF LONGTERM (LT) NASOBILIARY DRAINAGE (NBD) IN THREE PATIENTS WITH INTRACTABLE PRURITUS. THIS CASE SERIES TESTS THE HYPOTHESIS THAT LT-NBD COULD BE SUCCESSFULLY USED TO ALLEVIATE CHOLESTASIS RELATED PRURITUS, AND PREVENT OR DELAY THE NEED FOR LIVER TRANSPLANTATION. 3 PATIENTS WERE INVOLVED IN THIS STUDY. ((B)(6), 2014) THE COMPLAINT FILES (B)(4) WERE RAISED AS A RESULT OF THIS LITERATURE ARTICLE. (B)(4) WAS OPENED TO CAPTURE PAIN AND INCREASED SERUM LEVELS ADVERSE EVENTS. THIS FILE WAS OPENED TO CAPTURE THE CASE OF USER ERROR, OCCLUSION AND BLOCKAGE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0129) STATES THE FOLLOWING: ¿POTENTIAL ADVERSE EVENTS ASSOCIATED WITH NASAL BILIARY DRAINAGE INCLUDE BUT ARE NOT LIMITED TO BLOCKAGE OF THE DRAINAGE CATHETER, OBSTRUCTION OF THE PANCREATIC DUCT ¿ IT SHOULD BE NOTED THE IFU STATES ¿THIS DEVICE IS NOT INTENDED FOR USE BEYOND 29 DAYS¿. THERE IS SUFFICIENT EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF A USER ERROR SITUATION WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. IT IS NOTED IN THE INFORMATION PROVIDED, THE DEVICE EXCEEDED THE RECOMMENDED INDWELL PERIOD OF 29 DAYS. IT IS LIKELY THE USER ERROR CONTRIBUTED TO THE OCCLUSION AND BLOCKAGE THAT 1 OF THE 7 CASES EXPERIENCED. IT SHOULD BE NOTED THAT, AS THE DEVICES WERE USED OUTSIDE OF THEIR VALIDATED STATE AND/OR AGAINST THE INSTRUCTIONS PROVIDED IN THE IFU, IT IS NOT POSSIBLE TO PREDICT HOW THE DEVICES WILL PERFORM OR FUNCTION. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, PATIENT EXPERIENCED CESSATION OF FLOW OF BILE WHICH WAS OVERCOME BY FLUSHING THE CATHETER. TUBE REOCCLUSION ¿ REQUIRED A REPEAT ERCP PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    APPLEBY, SAFETY AND EFFICACY OF LONG-TERM NASOBILIARY DRAINAGE TO TREAT INTRACTABLE PRURITUS IN CHOLESTATIC LIVER DISEASE. LT-NBD WAS CARRIED OUT IN THREE FEMALE PATIENTS (MEAN AGE 43 YEARS) FOR INTRACTABLE PRURITUS. NBD WAS CARRIED OUT THROUGH THE ENDOSCOPIC PLACEMENT OF A 6 FRENCH 250 CM COOK MEDICAL NASOBILIARY CATHETER INTO THE COMMON BILE DUCT. A SPHINCTEROTOMY WAS PERFORMED IN PATIENT 2 WITH PBC TO FACILITATE DEEP CANNULATION OF THE DUCT. THE POSITION OF THE NASOBILIARY CATHETER WAS CONFIRMED UNDER SCREENING. THE ONLY OTHER COMPLICATION DOCUMENTED, IN RELATION TO NBD WAS THAT OF LUMINAL OCCLUSION AND CESSATION OF FLOW OF BILE. IN THE FIRST INSTANCE, THIS COMPLICATION WAS OVERCOME BY FLUSHING THE CATHETER WITH NORMAL SALINE AND COMMENCING UDCA, HOWEVER ON TUBE REOCCLUSION, A REPEAT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND CATHETER CHANGE WAS CARRIED OUT. (TUBE REPLACEMENT AFTER 10 MONTHS DUE TO BLOCKAGE OF THE CATHETER LUMEN). IN THE SECOND PATIENT WITH PBC, LT-NBD WAS CARRIED OUT OVER 14 MONTHS, WITH COMPLETE RESOLUTION OF PRURITUS (TUBE REPLACED THREE TIMES). NOTE: PER THE IFU THE INDWELLING TIME OF 29 DAYS WAS EXCEEDED THROUGHOUT THE STUDY. THIS FILE WILL CAPTURE THE 6 INSTANCE OF EXCEEDING INDWELLING TIME WHERE 1 DEVICE POTENTIALLY WHICH LED TO LUMINAL OCCLUSION AND CESSATION OF FLOW OF BILE. CESSATION OF FLOW OF BILE WAS OVER COME BY FLUSHING THE CATHETER. TUBE REOCCLUSIUON ¿ REQUIRED A REPEAT ERCP PROCEDURE.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 20-JAN-23.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909453 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention