BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL BILIARY DRAINAGE SET

    MDR report key: 14853767 · Received June 29, 2022

    Report

    Report Number
    3001845648-2022-00383
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    January 22, 2022
    Report Date
    February 14, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 NASAL BILIARY DRAINAGE SET 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 ALL 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 COMPLAINT WAS RAISED IN THE LITERATURE ARTICLE YONGJIANG BA, 2020 - PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE MAY BE THE PREFERRED PREOPERATIVE DRAINAGE METHOD IN HILAR CHOLANGIOCARCINOMA. THE GOAL OF THIS STUDY WAS TO COMPARE THE CLINICAL OUTCOME AND ASSOCIATED COMPLICATIONS FOR TYPES II, III, AND IV HC MANAGED BY PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) COMPLAINT FILES (B)(4), (B)(4) AND (B)(4) WERE OPENED AS A RESULT OF THIS PAPER. (B)(4) (EMDR#3001845648-2022-00384)WAS OPENED TO CAPTURE PANCREATITIS (ERCP) - NINETEEN OF 180 PATIENTS (10.56%) DEVELOPED POST-PROCEDURE PANCREATITIS. (B)(4)(EMDR#3001845648-2022-00386) WAS OPENED TO CAPTURE CHOLANGITIS (ERCP) ¿ 5 OF 180 PATIENTS (2.7%) DEVELOPED POST-PROCEDURE CHOLANGITIS. THIS FILE WAS OPENED TO CAPTURE HEMOBILIA. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0129) STATES THE FOLLOWING: ¿POTENTIAL ADVERSE EVENTS ASSOCIATED WITH ERCP INCLUDE BUT ARE NOT LIMITED TO HEMORRHAGE¿. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE ERCP PROCEDURE ITSELF. AS PER THE IFU, HAEMORRHAGE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ERCP PROCEDURES¿ CLINICAL INPUT WAS SOUGHT AND IT WAS CONFIRMED THE BLOCKAGE NOTED WAS NOT RELATED TO THE COOK ENBD DEVICE THE BLOCKAGE WAS DUE TO THE PTBD PROCEDURE AND WAS IRRELEVANT TO ENBD DEVICE BEING PLACED VIA ERCP. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 2 PATIENTS EXPERIENCED HEMOBILIA, IT IS NOT CLEAR FROM THE LITERATURE PAPER WHETHER OR NOT THE PATIENTS REQUIRED INTERVENTION HOWEVER CLINICAL INPUT SUGGESTS THAT THEY WOULD HAVE REQUIRED INTERVENTION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE ERCP PROCEDURE ITSELF. AS PER THE IFU, HAEMORRHAGE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ERCP PROCEDURES COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    YONGJIANG BA, 2020 - PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE MAY BE THE PREFERRED PREOPERATIVE DRAINAGE METHOD IN HILAR CHOLANGIOCARCINOMA. DRAINAGE METHOD ERCP: WHEN PERFORMING ERCP, BILE DUCT CANNULATION AND CHOLANGIOGRAM PROCEDURES WERE COMPLETED BY USING A DUODENOSCOPE (TJF-260V, OLYMPUS, JAPAN). IN A GENERAL WAY, THE GUIDE WIRE WAS INSERTED AND CROSSED OVER THE MALIGNANT OBSTRUCTION SITE TO THE PROXIMAL END OF THE HEPATIC BILE DUCT. CONSIDERING THAT PATIENTS MAY UNDERGO RADICAL CHOLANGIOCARCINOMA RESECTION WHEN JAUNDICE REDUCTION IS SATISFACTORY, ONE OR TWO PLASTIC BILIARY STENTS OR ENDOSCOPIC NASOBILIARY DRAINS WERE PLACED (8.5 FR; BOSTON SCIENTIFIC, UNITED STATES OR OLYMPUS, JAPAN. IF THE GUIDE WIRE FIRST ENTERED THE BILE DUCT ON THE SIDE OF THE FUTURE REMNANT LOBE, A UNILATERAL PLASTIC STENT OR ENBD WAS USUALLY PLACED; IF THE GUIDE WIRE ENTERED THE BILE DUCT OF THE NON-FUTURE REMNANT LOBE FIRST AND THEN THE BILE DUCT OF THE FUTURE REMNANT LOBE WAS SELECTED, BILATERAL BILIARY STENTS WERE PLACED SIDE BY SIDE. 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. THIS COMPLAINT CAPTURES HAEMOBILIA IN 2 PATIENTS IN THE ERCP GROUP, 1 CASE WITH BLOCKAGE OF DRAINAGE TUBE CAUSED BY HAEMOBILIA.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE CORRECTIONS MADE TO DESCRIPTION OF EVENT ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846736 NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention