BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHIKAI BLACK

    MDR report key: 22517105 · Received July 16, 2025

    Report

    Report Number
    3003775027-2025-00177
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 20, 2025
    Report Date
    July 16, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    MOF
    UDI-DI
    04547327132015
    PMA / PMN Number
    K141751
    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). ALTHOUGH CHIKAI BLACK IS CURRENTLY US MARKETED, THE SUBJECT MODEL IS SOLD ONLY OUTSIDE THE US. 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 CHIKAI BLACK GUIDE WIRE WAS RETURNED FOR EVALUATION. ORIGINATING FROM APPROXIMATELY 180MM DISTAL TO THE PROXIMAL SOLDER (SET AT 300MM FROM THE TIP FOR THE PURPOSE OF FIXING THE OUTER COIL ONTO THE CORE WIRE), THE OUTER COIL WAS FOUND STRETCHED. THE POLYMER JACKET WAS TORN OFF AT APPROXIMATELY 250MM DISTAL TO THE PROXIMAL SOLDER. THE POLYMER JACKET WAS THEN REMOVED TO OBSERVE THE CORE WIRE AND THE COILS. BOTH THE OUTER COIL AND THE INNER COIL WERE STRETCHED BY TENSILE STRESS WITH WIDENED COIL PITCHES, NEITHER OF WHICH WAS FRACTURED. THE CORE WIRE WAS FOUND FRACTURED AT APPROXIMATELY 299MM DISTAL TO THE PROXIMAL SOLDER. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND THAT THE FRACTURE END OF THE CORE WIRE WAS NECKED AND THE FRACTURE SURFACE HAD SMALL DIMPLES, WHICH ARE TRACES OF DUCTILE FRACTURE. THE FRACTURE SURFACE OF THE CORE WIRE ON THE DISTAL SIDE WAS OBSERVED AT THE SOLDER THAT WAS SET TO FIX THE DISTAL TIP, OUTER COIL, INNER COIL AND THE CORE WIRE. SMALL DIMPLES DUE TO TENSILE STRESS WERE ALSO OBSERVED ON THE FRACTURE SURFACE ON THE DISTAL SIDE. ALTHOUGH THE CORE WIRE OF THE RETURNED CHIKAI BLACK GUIDE WIRE WAS FRACTURED AT THE TIP SOLDER AND THE OUTER COIL WAS STRETCHED, MEASUREMENT OF THE RETURNED GUIDE WIRE AND CORRESPONDENCE OF THE CORE FRACTURE ENDS CONFIRMED THAT THE ENTIRE GUIDE WIRE WAS RETURNED. 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 VISUALLY INSPECTED FOR NO ANOMALY OF APPEARANCE. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TENSILE STRESS GENERATED WITH WIRE MANIPULATION MIGHT HAVE BEEN ACCUMULATED ON THE TIP OF THE CHIKAI BLACK GUIDE WIRE WHILE THE WIRE TIP WAS TRAPPED DUE TO TORTUOUS VESSEL OR THE LESION. CONSEQUENTLY, THE OUTER COIL, INNER COIL AND THE CORE WIRE WERE STRETCHED AND THE CORE WIRE WAS EVENTUALLY DETACHED FROM THE DISTAL TIP. IN THAT SITUATION, DIFFICULTY COULD BE MET DURING MANIPULATION OF THE CONCOMITANT DEVICE ON THE GUIDE WIRE. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, A POSSIBILITY COULD NOT BE RULED OUT THAT SOME WIRE FRAGMENT(S) MIGHT BE LEFT IN THE PATIENT ANATOMY IF IT WERE TO RECUR. 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 VESSEL 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. NEVER PUSH, AUGER, WITHDRAW, OR PRESS THIS GUIDE WIRE WITH ENOUGH FORCE TO FEEL RESISTANCE. PRESSING OR PUSHING THIS GUIDE WIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR TIP SEPARATION OF THIS GUIDE WIRE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE TIP OF THE GUIDE WIRE. IF THE PROLAPSE OF THE GUIDE WIRE TIP IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION. OTHERWISE, DAMAGE TO THE GUIDE WIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BE DAMAGED INCLUDING SEPARATION OR THE LIKE, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. [MALFUNCTIONS AND ADVERSE EVENTS] BREAKAGE OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED CONCOMITANT DEVICE COULD NOT BE INSERTED ALONG AN ASAHI CHIKAI BLACK GUIDE WIRE DURING A CAROTID ARTERY STENTING. THE PROCEDURE WAS COMPLETED WITH A NEW CHIKAI BLACK GUIDE WIRE. IT WAS INFORMED THAT THERE WAS NO ADVERSE PATIENT EFFECT AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168499 CHIKAI BLACK NEUROVASCULAR GUIDE WIRE MOF ASAHI INTECC CO., LTD. AIN-CKI-200-BSR 241024A14A 04547327132015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown