BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 10028629 · Received May 6, 2020

    Report

    Report Number
    3001845648-2020-00277
    Event Type
    Injury
    Date Received
    May 6, 2020
    Date of Event
    January 1, 2013
    Report Date
    March 2, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE RPN OF THIS DEVICE IS UNKNOWN THE 510K # FOR THE ENBD PRODUCT FAMILY IS K180868. DEVICE EVALUATION THE UNKNOWN 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 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0099-0 / IFU0129-0) LISTS CHOLANGITIS AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ERCP AND NASAL BILIARY DRAINAGE PROCEDURES. 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 AND/OR THE PROCEDURE WHEREBY THE CATHETER WAS PLACED. AS PER THE IFU, CHOLANGITIS IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ERCP AND NASAL BILIARY DRAINAGE PROCEDURES. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 24 PATIENTS REQUIRED ADDITIONAL DRAINAGE OR ENBD EXCHANGE AS A RESULT OF THIS EVENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    AS THE RPN OF THIS DEVICE IS UNKNOWN THE 510K # FOR THE ENBD PRODUCT FAMILY IS K180868. DEVICE EVALUATION: THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS 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 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0099-0 / IFU0129-0) LISTS CHOLANGITIS AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ERCP AND NASAL BILIARY DRAINAGE PROCEDURES. IMAGE REVIEW : N/A. 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 AND/OR THE PROCEDURE WHEREBY THE CATHETER WAS PLACED. AS PER THE IFU, CHOLANGITIS IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ERCP AND NASAL BILIARY DRAINAGE PROCEDURES. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 24 PATIENTS REQUIRED ADDITIONAL DRAINAGE OR ENBD EXCHANGE AS A RESULT OF THIS EVENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON (B)(6) 2021.

    Description of Event or Problem · 0

    THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO AMEND THE IMDRF E CODE OF THE PREVIOUSLY SUBMITTED REPORT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. AS THE RPN OF THIS DEVICE IS UNKNOWN THE 510K # FOR THE ENBD PRODUCT FAMILY IS K180868.

    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. 47 CASES OF POST-ENBD CHOLANGITIS, 24 OF WHICH REQUIRED ADDITIONAL INTERVENTION - ADDITIONAL DRAINAGE OR ENBD CATHETER EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492080 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention