BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIELDER 18

    MDR report key: 21810853 · Received April 9, 2025

    Report

    Report Number
    3003775027-2025-00099
    Event Type
    Injury
    Date Received
    April 9, 2025
    Report Date
    April 10, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    OCY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    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 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. AS THERE WERE NO DETAILED DESCRIPTIONS IN THE LITERATURE ABOUT HOW THE ASAHI FIELDER 18 GUIDE WIRE WAS INVOLVED WITH THE REPORTED EUS-HGS, THE CAUSE OF THE REPORTED ADVERSE EVENTS OR HOW WHICH DEVICES WERE INVOLVED COULD NOT BE IDENTIFIED WITH THE LITERATURE. REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT PATIENT ANATOMY AND OPERATOR'S TECHNIQUE WERE MOST LIKELY ASSOCIATED WITH SUCH ADVERSE EVENTS AS BILE LEAKAGE AND BLEEDING THAT HAD REPORTEDLY 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: [PRECAUTIONS] ~ IF ABNORMAL RESISTANCE IS FELT DURING USE OF THIS GUIDE WIRE, STOP THE OPERATION IMMEDIATELY. DETERMINE THE CAUSE OF RESISTANCE WITHIN THE ENDOSCOPE'S FIELD OF VIEW OR UNDER FLUOROSCOPY, AND TAKE ANY NECESSARY REMEDIAL ACTION. ~ 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] ~ PERITONITIS ~ BLEEDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LITERATURE THAT ASAHI FIELDER 18 GUIDE WIRE MIGHT HAVE CAUSED OR CONTRIBUTED TO BILE PERITONITIS AND BLEEDING. PUBLICATION: DIGESTIVE DISEASES AND SCIENCES (2025) 70:419-428 TITLE: FEASIBILITY OF ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY FOR MALIGNANT HILAR BILIARY OBSTRUCTION. EXCERPTS: METHODS [PATIENTS] WE REVIEWED A COHORT OF 100 CONSECUTIVE PATIENTS WHO UNDERWENT EUS-BD AS A DRAINAGE METHOD FOR MHBO AT FIVE CENTERS (KYUSHU UNIVERSITY, KYUSHU MEDICAL CENTER, KITAKYUSHU MUNICIPAL MEDICAL CENTER, BEPPU MEDICAL CENTER, AND NAKATSU MUNICIPAL HOSPITAL) BETWEEN APRIL 2017 AND MARCH 2023. NINE PATIENTS WHO UNDERWENT EUS-GUIDED HEPATICOJEJUNOSTOMY (EUS-HJS) AND SIX PATIENTS WHO UNDERWENT EUS-GUIDED HEPATICODUODENOSTOMY (EUS-HDS) FOR MHBO WERE EXCLUDED FROM THE INITIAL COHORT (SUPPLEMENTARY FIG. 1). [PROCEDURES] ALL PROCEDURES WERE PERFORMED BY FIVE ENDOSCOPISTS WHO WERE EXPERTS IN EUS-GUIDED DRAINAGE TECHNIQUES. A GUIDEWIRE (0.025-INCH VISIGLIDE2 GUIDEWIRE, OLYMPUS, TOKYO, JAPAN; ENDOSELECTER, BOSTON SCIENTIFIC, TOKYO, JAPAN; M-THROUGH, ASAHI INTECC CORP., AICHI, JAPAN; MICHISUJI, KANEKA MEDIX CORP, OSAKA, JAPAN; J-WIRE PROLOGUE, J-MIT, SHIGA, JAPAN; 0.018-INCH NOVAGOLD GUIDEWIRE, BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA; OR FIELDER, OLYMPUS, TOKYO, JAPAN) WAS CAREFULLY INSERTED INTO THE IHBD. RESULTS [PATIENTS' CHARACTERISTICS AND OUTCOMES] EIGHTY-FIVE PATIENTS WHO UNDERWENT EUS-HGS WERE INCLUDED IN THIS ANALYSIS.THE BASELINE CHARACTERISTICS AND RESULTS ARE SHOWN IN TABLES 1 AND 2. THE STUDY PATIENTS HAD A MEDIAN AGE OF 72 YEARS, WITH FEMALES ACCOUNTING FOR 31 OF THE 85 PATIENTS (36.5%) IN THE COHORT. THE RATES OF TECHNICAL AND CLINICAL SUCCESS WERE 87.1% AND 76.4%, RESPECTIVELY, WITH AES OCCURRING IN 11.8% OF PATIENTS (10 PATIENTS, AMONG WHOM FIVE HAD BILE PERITONITIS, THREE HAD A HEMORRHAGE, AND TWO EXPERIENCED STENT MIGRATION). MOST AES WERE RESOLVED USING CONSERVATIVE TREATMENT. OF THE THREE PATIENTS WHO EXPERIENCED MODERATE AES, ONE REQUIRED ENDOSCOPIC HEMOSTASIS FOR HEMORRHAGE, ONE UNDERWENT ADDITIONAL EUS-HGS DUE TO STENT MIGRATION TOWARD THE GASTRIC SIDE 8 MONTHS POST-PROCEDURE, AND ONE WAS MANAGED WITH ANTIBIOTICS FOR BILE PERITONITIS, RESULTING IN AN EXTENDED HOSPITAL STAY. DISCUSSION THE RATE OF AES IN THE PRESENT STUDY WAS 11.8%, AND THE MOST COMMON AE WAS BILE PERITONITIS. TABLE 1 PATIENTS' BASELINE CHARACTERISTICS PATIENTS --- 85 AGE, YEARS, MEDIAN (IQR) --- 72 (65-77.5) SEX --- N (%) MALE --- 54 (63.5%) FEMALE --- 31 (36.5%) TABLE 2 PATIENT OUTCOMES TOTAL PATIENTS, N --- 85 TECHNICAL SUCCESS, N (%) --- 74 (87.1%) CLINICAL SUCCESS, N (%) --- 65 (76.4%) ADVERSE EVENTS, N (%) --- 10 (11.8%) BILE PERITONITIS --- 5 HEMORRHAGE --- 3 STENT MIGRATION --- 2 SEVERITY OF ADVERSE EVENTS, N MILD --- 7 MODERATE --- 3 SEVERE --- 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470556 FIELDER 18 ENDOSCOPIC GUIDE WIRE OCY ASAHI INTECC CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other