BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 10396087 · Received August 12, 2020

    Report

    Report Number
    3001845648-2020-00496
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    May 22, 2019
    Report Date
    November 22, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # 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. 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, PATIENTS SUFFERED CHOLANGITIS WHICH PRESENTED WITH A LOW GRADE FEVER AFTER THE PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BA ET AL 2019 (UNKNOWN ENBD) "PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE MAY BE THE PREFERRED PREOPERATIVE DRAINAGE METHOD IN HILAR CHOLANGIOCARCINOMA". 180 ELIGIBLE PATIENTS WITH TYPE II, III, AND IV HILAR CHOLANGIOCARCINOMA WERE INCLUDED IN THIS STUDY . ACCORDING TO THE DRAINAGE METHOD, THE PATIENTS WERE DIVIDED INTO TWO GROUPS: ERCP GROUP AND PTBD GROUP. THE ERCP GROUP INCLUDED PATIENTS WHO UNDERWENT ENDOSCOPIC BILIARY STENTING (EBS) AND ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD). PROCEDURE: GENERALLY SPEAKING, ENBD WAS PERFORMED WHEN PATIENTS HAD DIFFICULTY DURING CONTRAST AGENT EXCRETION, OR WHEN BILE WAS THICK OR FULL OF DREGS, WHICH IS EASY TO CLOG DRAINAGE TUBES. THE UPPER EDGE OF PLASTIC STENTS AND THE TIP OF THE NASOBILIARY CATHETER (8 FR/10.2 FR; COOK MEDICAL, WINSTON-SALEM, NORTH CAROLINA, UNITED STATES) SHOULD CROSS OVER THE UPPER MARGIN OF THE MALIGNANT OBSTRUCTION SITE BY 2 CM. FIFTY-FIVE OF 180 PATIENTS (30.56 %) DEVELOPED POST-DRAINAGE CHOLANGITIS: 37 IN THE ERCP GROUP AND 18 IN THE PTBD GROUP. AMONG THEM, 46 CASES (83.64 %) OF POST-PROCEDURE ACUTE CHOLANGITIS WERE CONSIDERED AS BACTERIAL CONTAMINATION ORIGINATING FROM THE DUODENUM, EIGHT CASES (14.55 %) WITH DRAINAGE TUBE MIGRATION ((B)(4)) AND 1 CASE (1.81 %) WITH BLOCKAGE OF DRAINAGE TUBE CAUSED BY HEMOBILIA ((B)(4)). MOST FEVERS OCCURRED WITHIN 24 HOURS AFTER INTERVENTION. DIAGNOSTIC CRITERIA FOR ACUTE CHOLANGITIS WERE BASED ON THE TG13 TOKYO GUIDELINES AND INCLUDED:(1) UPPER ABDOMINAL PAIN (NRS = 4); (2) FEVER (> 38.0) AND/OR CHILLS; (3) SERUM TOTAL BILIRUBIN (TBIL) LEVEL 34.2 MOL/L; AND (4) INFLAMMATORY RESPONSE (WBC 10,000/L, CRP>1MG/DL). (EDIT DR 06-AUG-2020). THIS FILE WILL CAPTURE THE UNKNOWN NUMBER OF PATIENT WHO EXPERIENCED POST-DRAINAGE CHOLANGITIS CAUSING FEVER WITHIN 24 HOURS AFTER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860806 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention