BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTATO XS 40

    MDR report key: 19611909 · Received June 26, 2024

    Report

    Report Number
    3003775027-2024-00065
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 26, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327140409
    PMA / PMN Number
    K153443
    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: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749. THE REPORTED ASTATO XS 40 GUIDE WIRE WAS RETURNED FOR INVESTIGATION. THE RETURNED ASTATO XS 40 WAS FOUND WITH DISARRANGED COIL AT MULTIPLE LOCATIONS FOR APPROXIMATELY 10MM DISTAL TO THE PROXIMAL SOLDER. THE OUTER COIL WAS FOUND FRACTURED AT THE MID SOLDER (LOCATED AT 15MM FROM THE WIRE TIP). THE CORE WIRE WAS FOUND FRACTURED AT APPROXIMATELY 13MM DISTAL TO THE MID SOLDER. MICROSCOPIC OBSERVATION OF THE FRACTURE END OF THE CORE WIRE FOUND A FLAT FRACTURE SURFACE, INDICATING THAT ACCUMULATED TORSIONAL STRESS HAD CONTRIBUTED TO THE FRACTURE, AS WELL AS HELICAL MARKS ON THE SHAFT. THE FRACTURE END OF THE OUTER COIL WAS TWISTED, INDICATING THAT THE COIL FRACTURE WAS ATTRIBUTED TO TORSION GENERATED MOST LIKELY WHEN THE OUTER COIL WAS PULLED AND STRAIGHTENED. MEASUREMENT OF THE RETURNED ASTATO XS 40 GUIDE WIRE SUGGESTED THAT THE OUTER COIL WAS DETACHED AT APPROXIMATELY 15MM FROM THE WIRE TIP AND THE CORE WIRE WAS DETACHED AT APPROXIMATELY 2MM FROM THE WIRE TIP. 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 TORSIONAL STRESS MIGHT HAVE BEEN LOCALLY ACCUMULATED TO THE DISTAL SEGMENT OF THE SUBJECT ASTATO XS 40 GUIDE WIRE WHILE THE GUIDE WIRE TIP WAS CAUGHT BY THE CALCIUM. CONSEQUENTLY, THE CORE WIRE WAS FRACTURED. AS TENSION WAS APPLIED DURING WITHDRAWAL, THE OUTER COIL WAS STRETCHED AND FRACTURED AT THE MID SOLDER DUE TO TORSION APPLIED TO THE OUTER COIL. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: WARNINGS] OBSERVE GUIDE WIRE MOVEMENT IN THE VESSELS. BEFORE A GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE A 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 GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING WIRE MANIPULATIONS. NEVER PUSH, AUGER, WITHDRAW, OR TORQUE THIS GUIDE WIRE THAT MEETS RESISTANCE. TORQUING 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 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 RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDE WIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDE WIRE ITSELF. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, 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. THIS MAY CAUSE THE GUIDE WIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDE WIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720 DEGREES) IN THE SAME DIRECTION. [MALFUNCTION AND ADVERSE EFFECTS] SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) WAS PERFORMED FOR A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). AN ASAHI ASTATO XS 40 GUIDE WIRE AND A PROMINENT STIFF MICRO CATHETER (TOKAI MEDICAL PRODUCTS) WERE USED TOGETHER TO BE INSERTED INTO THE LESION; HOWEVER, THE DISTAL SEGMENT OF THE ASTATO XS 40 GUIDE WIRE GOT STUCK IN THE LESION. WHEN AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE WITH THE MICRO CATHETER, THE DISTAL SEGMENT OF THE GUIDE WIRE WAS DETACHED. AN UNSPECIFIED GUIDE WIRE WAS USED INSTEAD TO CONTINUE THE PROCEDURE. THE WIRE FRAGMENT WAS PRESSED AGAINST THE VESSEL WALL WITH AN UNSPECIFIED STENT, AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626130 ASTATO XS 40 PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. 231009A13A 04547327140409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability