BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI CONQUEST PRO 12

    MDR report key: 25198160 · Received May 18, 2026

    Report

    Report Number
    3003775027-2026-00101
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327138413
    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

    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 BRAND NAME OF THE SUBJECT DEVICE IS CONQUEST PRO 12, WHICH IS DISTRIBUTED AS CONFIANZA PRO 12 IN THE US. MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. THE REPORTED CONQUEST PRO 12 GUIDE WIRE WAS RETURNED FOR EVALUATION. THE OUTER COIL OF THE RETURNED GUIDE WIRE WAS FOUND FRACTURED AT THE TIP SOLDER (SET TO FIX THE DISTAL BALL TIP TO THE OUTER COIL), EXPOSING THE CORE WIRE, WHICH WAS SLIGHTLY BENT. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND THAT THE FRACTURE END OF THE OUTER COIL HAD AN UNEVEN FRACTURE SURFACE WITH SMALL DIMPLES, WHICH ARE TRACES OF DUCTILE FRACTURE. THERE WERE NO OTHER DAMAGES THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. MEASUREMENT OF THE RETURNED GUIDE 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 THE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TENSILE STRESS AND TORSION GENERATED WITH WIRE MANIPULATION MIGHT HAVE BEEN LOCALLY ACCUMULATED ON THE TIP SOLDER OF THE CONQUEST PRO 12 GUIDE WIRE WHILE THE WIRE TIP WAS TEMPORARILY CAUGHT BY THE HEAVILY CALCIFIED LESION. CONSEQUENTLY, THE OUTER COIL WAS DETACHED FROM THE DISTAL BALL TIP AND LOOKED LIKE STRETCHED. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. AS A POSSIBILITY COULD NOT BE RULED OUT THAT SOME WIRE FRAGMENT(S) MIGHT BE LEFT IN THE PATIENT ANATOMY IF IT WERE TO RECUR, THIS EVENT WAS DETERMINED TO BE REPORTABLE. 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 A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE SEGMENT #6 OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). REPEATED ATTEMPTS WERE MADE TO CRACK THE CALCIFIED LESION USING AN ASAHI CONQUEST PRO 12 GUIDE WIRE. THE GUIDE WIRE THEN GOT TRAPPED IN THE LESION AND THE WIRE TIP WAS STRETCHED. AN ASAHI CONQUEST PRO 12 ST GUIDE WIRE WAS THEN USED TO CONTINUE THE PROCEDURE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW. IT WAS INFORMED THAT THE PATIENT WAS FINE WITHOUT ANY ISSUES AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247409 ASAHI CONQUEST PRO 12 PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AGH143191P 250827A361 04547327138413

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown