BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIELDER 18

    MDR report key: 24684799 · Received March 25, 2026

    Report

    Report Number
    3003775027-2026-00046
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    OCY
    UDI-DI
    04547327134248
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: (B)(4). WHEN THE REPORTED PRODUCT WAS RETURNED TO THE MANUFACTURER, REPORTABLE MALFUNCTION WAS RECOGNIZED FOR THE FIRST TIME; THEREFORE, G3. DATE RECEIVED BY MANUFACTURER IS THE SAME AS THE DATE IN D9. RETURNED TO MANUFACTURER. THE REPORTED FIELDER 18 GUIDE WIRE WAS RETURNED FOR INVESTIGATION. THE PEEK COATING ON THE SHAFT OF THE FIELDER 18 GUIDE WIRE WAS FOUND PEELED OFF AT APPROXIMATELY 65-85MM FROM THE TIP. MICROSCOPIC OBSERVATION OF PEELED SEGMENT FOUND LONGITUDINAL PEELING OF THE PEEK COATING REACHING THE SHAFT CORE, WHICH WAS LIKELY CAUSED DUE TO INTERFERENCE WITH A RELATIVELY HARD AND SHARP-EDGED OBJECT. SCRATCH MARKS WERE FOUND NEAR THE END OF THE PEELING. THE OUTER DIAMETERS AT DISTAL SEGMENT AND SHAFT WERE WITHIN THE PRODUCT SPECIFICATIONS. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. IT WAS CONFIRMED THAT THE PRODUCTS WERE MANUFACTURED IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. ASAHI PRODUCTS ARE ALL INSPECTED FOR MEETING THEIR PRODUCT SPECIFICATION CRITERIA AS PART OF THE PRODUCTION PROCESS. THE GUIDE WIRES ARE VISUALLY INSPECTED FOR NO ANOMALY OF APPEARANCE. BASED ON THE OBTAINED INFORMATION AND THE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT THE SURFACE OF THE FIELDER 18 GUIDE WIRE MIGHT HAVE BEEN FORCIBLY SCRAPED BY THE CONCOMITANT DISPOSABLE BIOPSY NEEDLE, CAUSING THE PEEK COATING TO BE PEELED OFF. CONSEQUENTLY, RESISTANCE WOULD BE INCREASED BETWEEN THE GUIDE WIRE AND THE CONCOMITANT DISPOSABLE BIOPSY NEEDLE. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO THE PRODUCT QUALITY. GIVEN THE SEVERE DAMAGE OBSERVED ON THE RETURNED DEVICE, IT WAS UNABLE TO COMPLETELY RULE OUT A POSSIBILITY THAT FRAGMENTED PEEK COATING MIGHT BE LEFT IN THE PATIENT ANATOMY. NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] THIS GUIDE WIRE IS COATED WITH POLYTETRAFLUOROETHYLENE (PTFE), POLYETHER ETHER KETONE (PEEK) AND A HYDROPHILIC POLYMER. FAILURE TO FOLLOW THE INSTRUCTIONS PROVIDED UNDER "WARNINGS" AND "PRECAUTIONS" MAY CAUSE DAMAGE TO THE COATING AND REQUIRE MEDICAL INTERVENTION OR LEAD TO SEVERE ADVERSE EFFECTS. [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. WHEN USING THIS GUIDE WIRE WITH A METAL NEEDLE, USE A METAL NEEDLE HAVING A SINGLE APEX AND NO SIDE HOLE. WHEN USING THIS GUIDE WIRE WITH A METAL NEEDLE, OPERATE (PUSH OR PULL WITH ROTATION) ONLY THE RADIOPAQUE PORTION AT THE DISTAL END OF THIS GUIDE WIRE FOR NOT MORE THAN 5 TIMES. OPERATION OF THE PART PROXIMAL TO THE DISTAL RADIOPAQUE PORTION OF THIS GUIDE WIRE MUST BE LIMITED TO PUSHING. [MALFUNCTIONS AND ADVERSE EFFECTS] PEELING OF COATING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTERVENTIONAL ENDOSCOPIC ULTRASONOGRAPHY -GUIDED HEPATICOGASTROSTOMY (EUS-HGS) WAS PERFORMED FOR THE BILE DUCT. THE PHYSICIAN TRIED TO INSERT AN ASAHI FIELDER 18 GUIDE WIRE INTO AN UNSPECIFIED DISPOSABLE BIOPSY NEEDLE. HOWEVER, STRONG RESISTANCE WAS MET AND THE SUBJECT FIELDER 18 GUIDE WIRE COULD NOT BE INSERTED INTO THE DISPOSABLE BIOPSY NEEDLE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. IT WAS INFORMED THAT THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT AND THERE WAS NO PROBLEM OF THE PATIENT'S CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746003 FIELDER 18 ENDOSCOPIC GUIDE WIRE OCY ASAHI INTECC CO., LTD. E0018450AG-2 241212S02A 04547327134248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other