BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTATO XS 9-12

    MDR report key: 22313018 · Received June 24, 2025

    Report

    Report Number
    3003775027-2025-00167
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 28, 2025
    Report Date
    June 24, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327131261
    PMA / PMN Number
    K171933
    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 DEVICE IS SOLD OUTSIDE THE US IN A DIFFERENT BRAND NAME BUT IS SIMILAR IN STRUCTURE AND CONSTRUCTION AS A CURRENTLY US MARKETED DEVICE, CONFIANZA PRO 12 (K171933). 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 ASTATO XS 9-12 GUIDE WIRE WAS RETURNED FOR EVALUATION. AT APPROXIMATELY 6MM FROM THE TIP, THE OUTER COIL WAS STRETCHED AND THE CORE WIRE WAS FRACTURED. THE OUTER COIL WAS REMOVED FOR OBSERVATION PURPOSE. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND THAT EACH FRACTURE END OF THE CORE WIRE WAS TWISTED AND HAD A FLACT FRACTURE SURFACE, INDICATING THAT TORSION HAD CONTRIBUTED TO THE FRACTURE OF THE CORE WIRE. INVESTIGATION OF THE RETURNED GUIDE WIRE SUGGESTED THAT THE CORE WIRE WAS FRACTURED AT APPROXIMATELY 6MM FROM THE TIP WHILE THE OUTER COIL WAS NOT FRACTURED. MEASUREMENT OF THE CORE WIRE 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. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TORSION GENERATED WITH WIRE MANIPULATION MIGHT HAVE BEEN LOCALLY ACCUMULATED ON THE ASTATO XS 9-12 GUIDE WIRE WHILE THE WIRE TIP WAS TRAPPED BY THE HEAVILY CALCIFIED LESION, FRACTURING THE CORE 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 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 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. [MALFUNCTIONS AND ADVERSE EVENTS]. BREAKAGE OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI ASTATO XS 9-12 GUIDE WIRE WAS USED DURING A PLAIN OLD BALLOON ANGIOPLASTY (POBA) FOR A HEAVILY CALCIFIED, MILDLY TORTUOUS CHRONIC TOTAL OCCLUSION (CTO) IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING MANIPULATION INSIDE THE CTO BODY, THE GUIDE WIRE GOT STUCK WITH THE CONCOMITANT PROMINENT MICROCATHETER. WHEN THE TWO DEVICES WERE REMOVED FROM THE PATIENT ANATOMY, THE DEVICES COULD BE SEPARATED FROM EACH OTHER. AS IT WAS DETERMINED THAT IT WOULD BE DIFFICULT TO CONTINUE USING THE DEVICES AS THEY WERE, A NEW ASTATO XS 9-12 GUIDE WIRE AND PROMINENT MICROCATHETER WERE USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER THE DILATION OF THE LESION. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390333 ASTATO XS 9-12 PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. PAGH143091R 230913A10A 04547327131261

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown