BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHIKAI BLACK 18

    MDR report key: 17705820 · Received September 7, 2023

    Report

    Report Number
    3003775027-2023-00084
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    August 11, 2023
    Report Date
    September 8, 2023
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    MOF
    UDI-DI
    04547327098216
    PMA / PMN Number
    K141751
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: (B)(4) . THE SEPARATED TIP FRAGMENT OF THE REPORTED CHIKAI BLACK 18 GUIDE WIRE WAS RETURNED FOR EVALUATION. THE RETURNED TIP FRAGMENT WAS ABOUT 340MM LONG. THE PROXIMAL SEGMENT OF THE GUIDE WIRE WAS NOT RETURNED. THE BALL TIP WAS ATTACHED AT THE VERY DISTAL END OF THE WIRE FRAGMENT. THE WIRE FRAGMENT WAS FOUND HELICALLY CURVED THROUGHOUT ITS LENGTH. A KINK WAS OBSERVED AT APPROXIMATELY 135MM FROM THE TIP. AT APPROXIMATELY 340MM FROM THE TIP, THE POLYMER JACKET WAS TORN, EXPOSING THE FRACTURED COIL. THE POLYMER JACKET WAS THEN REMOVED FOR OBSERVATION. THE CORE WAS FOUND FRACTURED AT APPROXIMATELY 135MM FROM THE TIP AT THE KINKED SEGMENT. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND A CONCENTRIC-CIRCLE PATTERN OF DIMPLES ON THE RELATIVELY FLAT FRACTURE SURFACE OF THE CORE. THESE FINDINGS INDICATED THAT ACCUMULATED TORSION HAD CONTRIBUTED TO THE OBSERVED FRACTURE OF THE CORE. THE COIL FRACTURE END WAS THEN OBSERVED UNDER THE SEM. NECKING OF THE COIL FRACTURE END WAS OBSERVED, INDICATING TENSILE STRESS HAD CONTRIBUTED TO THE COIL FRACTURE. 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 PROVIDED INFORMATION AND THE ABOVE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TORSION GENERATED WITH TORQUING MANIPULATION WAS LOCALLY ACCUMULATED ON THE TIP OF CHIKAI BLACK 18 LIKELY WHEN THE MOVEMENT OF THE WIRE TIP WAS RESTRICTED BY THE ANATOMY, FRACTURING THE CORE. AS FURTHER TENSILE STRESS GENERATED WITH REMOVAL OF THE GUIDE WIRE WAS APPLIED, THE COIL AND THE POLYMER JACKET WERE STRETCHED, TEARING THE POLYMER JACKET AND FRACTURING THE GUIDE WIRE. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. BECAUSE THE PROXIMAL SEGMENT OF THE CHIKAI BLACK 18 GUIDE WIRE WAS NOT RETURNED, IT WAS UNABLE TO COMPLETELY RULE OUT THE POTENTIALITY THAT SOME WIRE FRAGMENTS MIGHT BE LEFT IN THE PATIENT. 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 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 OR TIP SEPARATION OF THIS GUIDE WIRE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT 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. ~ 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. [MALFUNCTION AND ADVERSE EFFECTS] ~ DAMAGE SUCH AS SEPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI CHIKAI BLACK 18 GUIDE WIRE WAS USED DURING THROMBUS RETRIEVAL TO TREAT A 90-99% STENOSIS IN AN UNSPECIFIED VESSEL. DURING WIRE MANIPULATION, RESISTANCE WAS MET AND THE TIP OF THE CHIKAI BLACK 18 GUIDE WIRE WAS DETACHED. THE TIP FRAGMENT (ABOUT 300MM LONG) REMAINED INSIDE A CONCOMITANTLY USED MEDTRONIC REBAR MICROCATHETER. THE TIP FRAGMENT WAS ABLE TO BE TRAPPED WITH AN UNSPECIFIED BALLOON CATHETER AND THE WHOLE SYSTEM WAS REMOVED. THE DEVICES WERE THEN EXCHANGED TO RESUME THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948247 CHIKAI BLACK 18 NEUROVASCULAR GUIDE WIRE MOF ASAHI INTECC CO., LTD. NA 210713A44A 04547327098216

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O