BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIELDER 18

    MDR report key: 19592204 · Received June 24, 2024

    Report

    Report Number
    3003775027-2024-00063
    Event Type
    Injury
    Date Received
    June 24, 2024
    Report Date
    June 24, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    OCY
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE IDENTIFIED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICES WERE DISCARDED AND NOT RETURNED FROM THE USER FACILITY. LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED BECAUSE LOT INFORMATION WAS UNAVAILABLE. ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS AND SATISFIED THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA; THEREFORE, IT WAS CONCLUDED THAT THERE WAS NO ANOMALY IN PRODUCT QUALITY. NO MENTION WAS MADE IN THE PRESENTATION THAT THE ASAHI FIELDER 18 GUIDE WIRE WAS DIRECTLY INVOLVED IN THE REPORTED ADVERSE EVENTS. REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT PATIENT ANATOMY AND PROCEDURAL CONTENTS WERE MOST LIKELY ASSOCIATED WITH SUCH ADVERSE EVENTS AS HEMORRHAGE AND BILE DUCT PERFORATION THAT HAD OCCURRED DURING THIS STUDY. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] OPERATE THIS GUIDE WIRE OR THE INTERVENTIONAL DEVICE SLOWLY AND CAREFULLY WHILE MONITORING THE MOVEMENT AND POSITION OF THIS GUIDE WIRE WITHIN THE ENDOSCOPE'S FIELD OF VIEW OR UNDER FLUOROSCOPY. [MALFUNCTION AND ADVERSE EFFECTS] PERFORATION BLEEDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A PRESENTATION AT AN ACADEMIC CONFERENCE THAT ASAHI FIELDER 18 GUIDE WIRE MIGHT HAVE CAUSED OR CONTRIBUTED TO HEMORRHAGE AND BILE DUCT PERFORATION. CONFERENCE: THE 107TH CONGRESS OF THE JAPAN GASTROENTEROLOGICAL ENDOSCOPY SOCIETY TITLE: EFFICIENCY AND USEFULNESS OF ULTRASOUND ENDOSCOPIC ANTEGRADE INTERVENTION FOR BILIARY STONE WITH SURGICALLY ALTERED GASTROINTESTINAL ANATOMY EXCERPTS ARE AS FOLLOWS: OBJECTIVES: RECENTLY, USEFULNESS OF ENDOSCOPIC ULTRASOUND ANTEGRADE INTERVENTION (EUS-AI) FOR BILIARY STONE WITH SURGICALLY ALTERED GASTROINTESTINAL ANATOMY HAS BEEN REPORTED. THIS STUDY AIMED TO ASSESS EFFICACY AND USEFULNESS OF EUS-AI AND BALLOON ASSISTED ENDOSCOPE-GUIDED RETROGRADE CHOLANGIOPANCREATOGRAPHY (BAE-ERCP). METHODS: THIS WAS A SINGLE-CENTER, RETROSPECTIVE COHORT STUDY OF 49 PATIENTS WITH BILIARY STONE WITH SURGICALLY ALTERED GASTROINTESTINAL ANATOMY WHO UNDERWENT ENDOSCOPE-GUIDED BILIARY STONE REMOVAL FROM APRIL 2018 TO DECEMBER 2023. CLINICAL OUTCOME WAS RETROSPECTIVELY COMPARED BETWEEN GROUP E (EUS-AI) AND GROUP B (BAE-ERCP). ALL OF THE PATIENTS OF GROUP E RECEIVED A TWO-STEP PROCEDURE CONSISTING OF STEP 1, ENDOSCOPIC ULTRASOUND HEPATICOGASTROSTOMY (EUS-HGS) OR ENDOSCOPIC ULTRASOUND HEPATICOJEJUNOSTOMY (EUS-HJS), AND STEP 2, ANTEGRADE BILIARY STONE EXTRACTION INTERVENTION (AI). DURING EUS-HGS OR EUS-HJS, ASAHI FIELDER 18 GUIDE WIRES (MARKETED BY OLYMPUS MEDICAL SYSTEMS) WERE USED FOR 20 PATIENTS. RESULTS: OF ALL 49 PATIENTS, 20 PATIENTS WERE INCLUDED IN GROUP E (15 PATIENTS WITH CHOLEDOCHOLITHIASIS AND 5 PATIENTS WITH INTRAHEPATIC GALLSTONE) WHILE 29 PATIENTS IN GROUP B (23 PATIENTS WITH CHOLEDOCHOLITHIASIS AND 6 PATIENTS WITH INTRAHEPATIC GALLSTONE). REPORTED ADVERSE EVENTS INCLUDED HEMORRHAGE (1 PATIENT) AND BILE DUCT PERFORATION (1 PATIENT) FROM GROUP E (10%), WHILE PANCREATITIS (3 PATIENTS) AND ABSCESS (1 PATIENT) FROM GROUP B (14%). NO SIGNIFICANT DIFFERENCE IN INCIDENCE OF ADVERSE EVENTS WAS OBSERVED BETWEEN THE TWO GROUPS. SUCCESSFUL BILE DUCT APPROACH, WHICH WAS DEFINED AS SUCCESSFUL STENT DEPLOYMENT TO THE INTRAHEPATIC BILE DUCT, WAS ACHIEVED 95% BY GROUP E AND 86.2% BY GROUP B (P=0.31). COMPLETE LITHOTOMY ACHIEVEMENT WAS 78.9% BY GROUP E AND 62.0% BY GROUP B (P=0.36). THESE RESULTS SUGGESTED THAT THE TREATMENT OUTCOME WAS EQUAL BETWEEN THE TWO GROUPS. ON THE OTHER HAND, THE AVERAGE TOTAL PROCEDURE TIME WAS 132 MINUTES FOR GROUP E BUT 238 MINUTES FOR GROUP B (P=0.004), WHILE THE MEDIAN TOTAL HOSPITALIZATION WAS 16 DAYS (14-36 DAYS) FOR GROUP E AND 17 DAYS (5-215 DAYS) FOR GROUP B (P=0.04), INDICATING THAT GROUP E HAD SIGNIFICANTLY SHORTER TOTAL PROCEDURE TIME AND SHORTER TOTAL HOSPITALIZATION THAN GROUP B. THE MEDIAN TIMES OF ENDOSCOPY WERE 2 TIMES (2-3 TIMES) FOR GROUP E AND 3 TIMES (1-11 TIMES) FOR GROUP B, WHILE THE ACCIDENTAL EVENT OCCURRENCE WAS 10.5% (1 HEPATORRHEA AND 1 HEMORRHAGE) FOR GROUP E AND 13.7% (3 PANCREATITIS AND 1 INTRAPERITONEAL ABSCESS) (P=0.70), WITHOUT SIGNIFICANT DIFFERENCE BETWEEN THE TWO GROUP. MULTIVARIATE ANALYSIS FOUND NO SIGNIFICANT PREDICTOR OF COMPLETE LITHOTOMY. MULTIVARIATE ANALYSIS ON THE TOTAL PROCEDURE TIME FOUND THAT BALLOON ASSISTED ENDOSCOPE-GUIDED INTERVENTION, DIAMETER OF COMMON BILE DUCT (>_10MM), PRESENCE OF ANASTOMOTIC STRICTURE, MULTIPLE BILIARY STONES, AND COMPLICATION BY CHOLANGITIS WERE SIGNIFICANTLY RELATED TO LONG PROCEDURE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194598 FIELDER 18 ENDOSCOPIC GUIDE WIRE OCY ASAHI INTECC CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other