BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 10396295 · Received August 12, 2020

    Report

    Report Number
    3001845648-2020-00494
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    May 22, 2019
    Report Date
    October 29, 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 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. HEMOBILIA IS NOT LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE INSTRUCTIONS FOR USE (IFU0099-0 / IFU0129-0) HOWEVER, AS PER CLINICAL INPUT IT IS KNOWN THAT HEMOBILIA RESULTED FROM ERCP OR PTBD PROCEDURE RELATED COMPLICATIONS. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. AS PER CLINICAL INPUT HEMOBILIA LIKELY RESULTED FROM ERCP OR PTBD PROCEDURE RELATED COMPLICATIONS AND WAS NOT RELATED TO THE DRAINAGE CATHETER ITSELF. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER 02 PATIENTS IN THE ERCP GROUP EXPERIENCED HEMOBILIA. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    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. ONE CASE OF POST DRAINAGE CHOLANGITIS CAUSED BY HEMOBILIA. ANOTHER CASE OF HEMOBILIA IS ALSO MENTIONED WITH LIMITED INFO. CLINICAL DIAGNOSIS OF HEMOBILIA CONSISTED OF: (1) BLOOD MIXED WITH BILE AFTER BILIARY DRAINAGE; (2) SLIGHT BLEEDING INDICATED BY A SMALL AMOUNT OF BLACK STOOL OR POSITIVE OCCULT BLOOD TEST; AND (3) MODERATE TO SEVERE BLEEDING, INDICATED BY A DROP IN HEMOGLOBIN OF 3 G/L, REQUIRING BLOOD TRANSFUSION, ANGIOGRAPHIC INTERVENTION, OR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861400 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention