BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHIKAI

    MDR report key: 10956005 · Received December 6, 2020

    Report

    Report Number
    3003775027-2020-00197
    Event Type
    Malfunction
    Date Received
    December 6, 2020
    Date of Event
    November 12, 2020
    Report Date
    November 18, 2020
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    MOF
    PMA / PMN Number
    K110584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED G4. EXPIRATION DATE, UNIQUE IDENTIFIER (UDI) #, H4 DEVICE MANUFACTURER DATE AND MANUFACTURING SITE BASED ON MANUFACTURING RECORDS RECEIVED ON DEC 17, 2020. MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: (B)(4). WHEN THE REPORTED DEVICE WAS RETURNED TO THE MANUFACTURER, REPORTABLE MALFUNCTION WAS RECOGNIZED FOR THE FIRST TIME; THEREFORE, THE DATE THE MANUFACTURER BECAME AWARE OF THIS EVENT WAS CONSIDERED THE DATE THE DEVICE WAS RETURNED. THE CHIKAI GUIDE WIRE WAS RETURNED FOR EVALUATION. THE COIL WIRE WAS STRETCHED FOR APPROXIMATELY 540MM FROM THE PROXIMAL MIDDLE SOLDER LOCATED AT 110MM FROM THE TIP. THE CORE WIRE WAS FOUND FRACTURED AT APPROXIMATELY 98MM DISTAL TO THE PROXIMAL MIDDLE SOLDER. OBSERVATION OF THE DISTAL SEGMENT OF THE STRETCHED COIL WIRE FOUND THAT THE COIL WIRE WAS STRETCHED FROM THE DISTAL MIDDLE SOLDER LOCATED AT 40MM FROM THE TIP, AND THE INNER COIL WIRE UNDER THE COIL WIRE WAS EXPOSED. AS THE END OF THE INNER COIL WIRE WAS FOUND WITH A CUT SURFACE MADE DURING THE PRODUCTION PROCESS, AND THE BALL TIP WAS ATTACHED ON THE VERY DISTAL END OF THE COIL WIRE, IT WAS CONCLUDED THAT THE INNER COIL WIRE AND COIL WIRE HAD NOT BEEN DETACHED. OBSERVATION OF THE FRACTURE SURFACE OF THE CORE WIRE UNDER A SCANNING ELECTRON MICROSCOPE (SEM) FOUND A CONCENTRIC DIMPLE PATTERN ON BOTH OF ITS PROXIMAL AND DISTAL FRACTURE SURFACES, WHICH WAS A TRACE OF FRACTURE DUE TO ACCUMULATION OF ROTATIONAL FORCE. A HELICAL PATTERN WAS FOUND ON THE SIDE OF THE CORE WIRE. BASED ON THE FINDINGS THAT THE COIL WIRE AND INNER COIL WIRE OF THE RETURNED CHIKAI WERE NOT DETACHED ALTHOUGH ITS CORE WIRE WAS FRACTURED AND COIL WIRE STRETCHED, AND FROM MEASUREMENT OF THE REMAINING LENGTH OF THE CORE WIRE, IT WAS CONCLUDED THAT THE TOTAL LENGTH OF THE CHIKAI GUIDE WIRE WAS RETURNED FOR EVALUATION. 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 INVESTIGATION OUTCOME, IT WAS PRESUMED THAT THE CORE WIRE OF THE CHIKAI MIGHT HAVE BEEN FRACTURED AS ROTATIONAL FORCE WAS LOCALLY ACCUMULATED DUE TO GUIDE WIRE MANIPULATION WHILE THE DISTAL SEGMENT OF THE GUIDE WIRE WAS CAUGHT IN THE TORTUOUS VESSEL. THE COIL WIRE COULD HAVE BEEN STRETCHED DUE TO PULLING FORCE APPLIED. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] 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; [WARNINGS] WHEN TORQUING THIS GUIDE WIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. IT MAY BE DAMAGED INCLUDING SEPARATION OR THE LIKE, WHICH MAY INJURE THE BLOOD VESSEL OR LEAVE FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDE WIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (UP TO 720?¿) IN THE SAME DIRECTION; AND, [MALFUNCTION AND ADVERSE EFFECTS] BREAKAGE OF THE GUIDE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL SEGMENT OF AN ASAHI CHIKAI GUIDE WIRE WAS DAMAGED DURING COIL EMBOLIZATION TO A CEREBRAL ANEURYSM. THE GUIDE WIRE WAS REPLACED WITH A NEW CHIKAI TO CONTINUE THE PROCEDURE. THE EMBOLIZATION WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421327 CHIKAI NEUROVASCULAR GUIDE WIRE MOF ASAHI INTECC CO., LTD. NA 200418A01A

    Patients

    Seq Age Sex Outcome Treatment
    1