BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIELDER FC

    MDR report key: 22858385 · Received August 21, 2025

    Report

    Report Number
    3003775027-2025-00195
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 21, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327123464
    PMA / PMN Number
    K163426
    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: TOYOFLEX CEBU CORPORATION, CEBU, PHILIPPINES, REGISTRATION NUMBER: (B)(4). ALTHOUGH FIELDER FC IS CURRENTLY US MARKETED, THE SUBJECT MODEL IS SOLD ONLY OUTSIDE THE US. THE REPORTED FIELDER FC GUIDE WIRE WAS RETURNED FOR EVALUATION WITH THE SEPARATED WIRE TIP. THE POLYMER JACKET OF THE RETURNED GUIDE WIRE WAS FOUND TORN OFF AT APPROXIMATELY 85MM DISTAL TO THE PROXIMAL SOLDER (SET AT 110MM FROM THE TIP TO FIX THE OUTER COIL ONTO THE CORE WIRE). THE OUTER COIL WAS STRETCHED FOR APPROXIMATELY 145MM FROM THE TORN END OF THE POLYMER JACKET AND THEN FRACTURED. THE POLYMER JACKET REMAINED INTERMITTENTLY ON THE OUTER COIL. THE POLYMER JACKET OF THE SEPARATED WIRE TIP WAS FOUND TORN OFF AT APPROXIMATELY 8MM PROXIMAL TO THE BALL TIP WHILE THE OUTER COIL WAS STRETCHED FOR APPROXIMATELY 11MM FROM THE TORN END OF THE POLYMER JACKET WAS THEN FRACTURED. THE POLYMER JACKET WAS REMOVED TO EXPOSE THE FRACTURE ENDS OF THE CORE WIRE. THE CORE WIRE WAS FOUND FRACTURED AT APPROXIMATELY 8MM FROM THE TIP AND AT APPROXIMATELY 102MM DISTAL TO THE PROXIMAL SOLDER. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND THAT BOTH PROXIMAL AND DISTAL FRACTURE ENDS OF THE CORE WIRE WERE NECKED DUE TO TENSILE STRESS. BOTH PROXIMAL AND DISTAL FRACTURE ENDS OF THE OUTER COIL WERE NECKED BY TENSILE STRESS AND HAD TRACES OF TORSION GENERATED MOST LIKELY WHEN THE COIL WIRE WAS PULLED AND STRAIGHTENED. 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 FIELDER FC GUIDE WIRE MIGHT HAVE BEEN TRAPPED DUE TO THE LESION OR TORTUOUS VESSEL. IN THAT SITUATION, TENSILE STRESS GENERATED WHEN THE GUIDE WIRE WAS GRASPED AND PULLED UP USING RETROGRADE TECHNIQUE WITH THE EN SNARE WAS LOCALLY APPLIED ON THE WIRE TIP, CAUSING THE WIRE TIP TO BE FRACTURED. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, IT WAS UNABLE TO COMPLETELY RULE OUT A POSSIBILITY THAT SOME POLYMER JACKET FRAGMENT(S) MIGHT BE LEFT IN THE PATIENT ANATOMY. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR TRAUMA MAY OCCUR. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE. IF RESISTANCE IS FELT BETWEEN THIS GUIDE WIRE AND THE OTHER INTERVENTIONAL DEVICES WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL, AVOID APPLYING EXCESSIVE FORCE. WHEN ABNORMAL RESISTANCE IS FELT, REMOVE THE ENTIRE SYSTEM FROM THE PATIENT'S BODY AND DETERMINE THE CAUSE. OTHERWISE, THE GUIDE WIRE MAY BREAK OR BE DAMAGED AND MAY CAUSE INJURY TO THE BLOOD VESSEL OR LEAVE FRAGMENTS INSIDE THE VESSEL. [MALFUNCTION AND ADVERSE EFFECTS] SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI FIELDER FC GUIDE WIRE WAS USED WITH AN ASAHI CORSAIR PRO XS MICROCATHETER VIA RETROGRADE APPROACH DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A MODERATELY TORTUOUS, HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE SEGMENT #1OF THE RIGHT CORONARY ARTERY (RCA). THE CORSAIR PRO XS MICROCATHETER COULD NOT BE ADVANCED NEAR THE SEGMENT #4 POSTERIOR DESCENDING BRANCH. THE LESION WAS CROSSED WITH THE FIELDER FC GUIDE WIRE ALONE. AS THE ANTEGRADE GUIDE CATHETER COULD NOT BE ENGAGED TO THE OSTIUM OF THE RCA AND WAS IN A FLOATING STATE, A NON-ASAHI EN SNARE WAS USED TO PULL THE FIELDER FC GUIDE WIRE AND THE COIL SEGMENT OF THE GUIDE WIRE WAS THEN FRACTURED. THE ENTIRE WIRE FRAGMENT WAS REMOVED USING THE SNARE AND THE CATHETER. THE PROCEDURE WAS THEN CONTINUED AND SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW. IT WAS INFORMED THAT THE PATIENT WAS FINE WITHOUT ANY ISSUES AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373569 FIELDER FC PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AGP140301R 250328A05F 04547327123464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other