BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIELDER 18

    MDR report key: 19611688 · Received June 26, 2024

    Report

    Report Number
    3003775027-2024-00064
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    May 30, 2024
    Report Date
    June 26, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    OCY
    UDI-DI
    04547327134248
    PMA / PMN Number
    EXEMPT
    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. THE REPORTED FIELDER 18 GUIDE WIRE WAS RETURNED FOR INVESTIGATION. THE COIL OF THE RETURNED FIELDER 18 GUIDE WIRE WAS FOUND ELONGATED FOR APPROXIMATELY 25CM FROM THE PROXIMAL SOLDER (SET AT 5CM FROM THE TIP TO FIX THE COIL ONTO THE CORE WIRE). THE BALL TIP WAS FOUND ATTACHED ON THE VERY DISTAL END OF THE ELONGATED COIL. MICROSCOPIC OBSERVATION FOUND THAT THE CORE WIRE WAS TWISTED, CURVED, AND FRACTURED AT APPROXIMATELY 3.8CM DISTAL TO THE PROXIMAL SOLDER. THE CORE WIRE WAS ALSO FOUND FRACTURED AT APPROXIMATELY 1.2CM PROXIMAL TO THE BALL TIP AT THE COIL END. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) OF FOUND A RELATIVELY FLAT FRACTURE SURFACE AT THE CORE FRACTURE END, AS WELL AS TRACES OF TORSION ON THE CORE SHAFT, INDICATING THAT TORSIONAL STRESS HAD CONTRIBUTED TO THE FRACTURE. MULTIPLE CIRCUMFERENTIAL CRACKS WERE ALSO FOUND ON THE CORE WIRE SHAFT, INDICATING THAT BENDING STRESS HAD BEEN APPLIED. THESE FINDINGS INDICATED THAT THE CORE WIRE WAS FRACTURED AT APPROXIMATELY 12MM PROXIMAL TO THE WIRE TIP, WHERE THE COIL WAS ELONGATED. 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 STRESS GENERATED WITH GUIDE WIRE MANIPULATION MIGHT HAVE BEEN LOCALLY ACCUMULATED AS EXCESSIVE ROTATIONAL STRESS AND BENDING STRESS ON THE DISTAL SEGMENT OF THE FIELDER 18 GUIDE WIRE, FRACTURING THE CORE WIRE. SUBSEQUENT WITHDRAWAL CAUSED THE COIL TO BE ELONGATED, WHICH COULD BE RECOGNIZED AS DELAMINATION OF HYDROPHILIC COATING ON THE DISTAL SEGMENT. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. HOWEVER, POSSIBILITY OF GUIDE WIRE FRACTURE SOME COATING FRAGMENTS MIGHT BE LEFT IN THE PATIENT ANATOMY COULD NOT BE COMPLETELY RULED OUT IF THE SAME EVENT RECURS. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [PRECAUTIONS] - IF ABNORMAL RESISTANCE IF 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. - DO NOT REPEATEDLY BEND THE SAME POSITION OF THE GUIDE WIRE OR CONTINUOUSLY ROTATE IT IN A CURVED DUCT FOR A LONG PERIOD OF TIME. [MALFUNCTION AND ADVERSE EFFECTS] - DAMAGE (BREAKAGE, BENDING, STRETCHING, SEPARATION).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT COATING OF AN ASAHI FIELDER 18 GUIDE WIRE WAS FOUND DELAMINATED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TO TREAT A STENOSED DISTAL BILE DUCT. THE PHYSICIAN DETERMINED TO CONTINUE USING THE FIELDER 18 GUIDE WIRE AND COMPLETED THE PROCEDURE. IT WAS INFORMED THAT THERE WERE NO ANOMALY WITH PATIENT HEALTH AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595788 FIELDER 18 ENDOSCOPIC GUIDE WIRE OCY ASAHI INTECC CO., LTD. 230208S01B 04547327134248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other