BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIELDER 18

    MDR report key: 20948224 · Received December 16, 2024

    Report

    Report Number
    3003775027-2024-00133
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 22, 2024
    Report Date
    December 17, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    OCY
    PMA / PMN Number
    D509384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: (B)(4). THE REPORTED FIELDER 18 GUIDE WIRE WAS RETURNED FOR EVALUATION. THE OUTER COIL WAS FOUND STRETCHED DISTALLY FOR APPROXIMATELY 210MM FROM THE PROXIMAL SOLDER (SET AT 50MM FROM THE TIP FOR THE PURPOSE OF FIXING THE OUTER COIL ONTO THE CORE). THE DISTAL TIP WAS FOUND ATTACHED ON THE STRETCHED OUTER COIL. THE CORE WAS FOUND FRACTURED AT APPROXIMATELY 22MM FROM THE TIP. THE PROXIMAL CORE FRACTURE END WAS FOUND OBSERVED AT APPROXIMATELY 28MM DISTAL TO THE PROXIMAL SOLDER. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND THAT EACH FRACTURE END OF THE CORE WAS BENT DUE TO BENDING FORCE AND HAD A FLAT FRACTURE SURFACE, INDICATING THAT ACCUMULATED TORSION HAD MOST LIKELY CONTRIBUTED TO THE CORE FRACTURE. PEELING OF COATING WAS NOT CONFIRMED THROUGHOUT THE LENGTH OF THE RETURNED GUIDE WIRE. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. ASAHI PRODUCTS ARE ALL INSPECTED FOR MEETING THEIR PRODUCT SPECIFICATION CRITERIA AS PART OF THE PRODUCTION PROCESS. THE GUIDE WIRES ARE INSPECTED FOR NO ANOMALY OF APPEARANCE. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT BENDING STRESS GENERATED WITH WIRE MANIPULATION MIGHT HAVE BEEN LOCALLY APPLIED ON THE CORE WHILE THE WIRE TIP WAS TEMPORARILY TRAPPED, CAUSING THE CORE TO BE BENT. FURTHER APPLIED TORSION WAS THEN ACCUMULATED, FRACTURING THE CORE. CONSEQUENTLY, THE OUTER COIL WAS STRETCHED DUE TO STRESS GENERATED WITH REMOVAL OF THE CONCOMITANT ANGIOGRAPHY TUBE. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, A POSSIBILITY COULD NOT BE COMPLETELY RULED OUT THAT SOME WIRE FRAGMENT(S) MIGHT BE LEFT IN THE PATIENT ANATOMY DUE TO THE CORE FRACTURE IF IT WERE TO RECUR, THIS EVENT WAS DETERMINED TO BE REPORTABLE. NO CAPA WILL BE TAKEN. 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. 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] BREAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COATING OF AN ASAHI FIELDER 18 GUIDE WIRE WAS PEELED WHEN IT WAS WITHDRAWN FROM THE CONCOMITANT ANGIOGRAPHY TUBE AT THE END OF AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE PEELED SEGMENT DID NOT FALL IN THE PATIENT ANATOMY. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT ANY ISSUES. THE PATIENT WAS REPORTEDLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485945 FIELDER 18 ENDOSCOPIC GUIDE WIRE OCY ASAHI INTECC CO., LTD. E0018450AG-2 230308S04A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown