BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIELDER 18

    MDR report key: 23188139 · Received October 1, 2025

    Report

    Report Number
    3003775027-2025-00213
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    August 27, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    OCY
    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: 3009121749. 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 OF THE RETURNED FIELDER 18 GUIDE WIRE WAS FOUND INTERMITTENTLY PEELED OFF AT APPROXIMATELY 150-160MM FROM THE DISTAL END. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. 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, THE RESISTANCE WOULD BE INCREASED BETWEEN THE GUIDE WIRE AND THE CONCOMITANT DISPOSABLE BIOPSY NEEDLE. EVENTUALLY, THE FIELDER 18 AND THE DISPOSABLE BIOPSY NEEDLE WERE STUCK TO EACH OTHER. 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 (EUS) WAS PERFORMED FOR THE BILE DUCT. THE PHYSICIAN TRIED TO INSERT AN ASAHI FIELDER 18 GUIDE WIRE INTO THE CONCOMITANT DISPOSABLE BIOPSY NEEDLE NA-U200H. HOWEVER, THE SUBJECT FIELDER 18 GUIDE WIRE AND THE DISPOSABLE BIOPSY NEEDLE GOT STUCK TO EACH OTHER. IT WAS INFORMED THAT THERE WAS NO ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673085 FIELDER 18 ENDOSCOPIC GUIDE WIRE OCY ASAHI INTECC CO., LTD. E0018450AG-2 241106S03A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other