BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI GLADIUS EX

    MDR report key: 23070231 · Received September 17, 2025

    Report

    Report Number
    3003775027-2025-00207
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327133968
    PMA / PMN Number
    K150445
    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 (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. 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, ASAHI GLADIUS14 (K150445). THE REPORTED GLADIUS EX GUIDE WIRE WAS RETURNED FOR EVALUATION TOGETHER WITH THE CONCOMITANT HIRYU PLUS BALLOON CATHETER. THE POLYMER JACKET OF THE RETURNED GLADIUS EX GUIDE WIRE WAS FOUND TORN OFF AT APPROXIMATELY 145MM FROM THE TIP AND PEELED FOR APPROXIMATELY 38MM. THE PEELED POLYMER JACKET WAS GATHERED DISTALLY. A POLYMER FRAGMENT OF THE GLADIUS EX GUIDE WIRE WAS FOUND COMING OUT OF THE TIP END OF THE CONCOMITANT HIRYU PLUS BALLOON CATHETER FOR APPROXIMATELY 5MM. IN ADDITION, DEFORMATION WAS OBSERVED AT THE DISTAL SEGMENT OF THE CATHETER 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 THE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT PRESSING STRESS MIGHT HAVE BEEN TEMPORARILY APPLIED TO THE CONCOMITANT HIRYU PLUS BALLOON CATHETER DUE TO ANATOMICAL AND LESION CONDITIONS, CAUSING THE LUMEN TO BE REDUCED IN SIZE AND THE TIP TO BE DEFORMED. CONSEQUENTLY, RESISTANCE WITH THE GLADIUS EX GUIDE WIRE WAS INCREASED, AND UNDER THESE CIRCUMSTANCES, PULLING MANIPULATION OF THE GUIDE WIRE LED TO PEELING AND SEPARATION OF THE POLYMER JACKET. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. 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. ~ 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. IF RESISTANCE IS FELT BETWEEN THIS GUIDE WIRE AND THE OTHER INTERVENTIONAL DEVICES WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL, AVOID APPLYING EXCESSIVE FORCE. WHEN ABNORMAL RESISTANCE IS FELT, REMOVE THE ENTIRE SYSTEM FROM THE PATIENT'S BODY AND DETERMINE THE CAUSE. OTHERWISE, THE GUIDE WIRE MAY BREAK OR BE DAMAGED AND MAY CAUSE INJURY TO THE BLOOD VESSEL OR LEAVE FRAGMENTS INSIDE THE VESSEL. [MALFUNCTIONS AND ADVERSE EFFECTS] ABRASION OF THE GUIDE WIRE COATING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A RE-OCCLUSION IN THE SEGMENT #1-3 OF THE RIGHT CORONARY ARTERY (RCA) WITH SEVERE TORTUOSITY AND HEAVY CALCIFICATION. AFTER CROSSING THE LESION WITH AN ASAHI GLADIUS EX GUIDE WIRE AND USING AN EXCIMER LASER, AN ATTEMPT WAS MADE TO ADVANCE A TERUMO HIRYU PLUS BALLOON CATHETER, BUT THE HIRYU PLUS BALLOON CATHETER BECAME STUCK WITH THE GLADIUS EX GUIDE WIRE. UPON REMOVAL AND INSPECTION OUTSIDE THE BODY, APPROXIMATELY 50MM OF THE POLYMER JACKET OF THE GLADIUS EX GUIDE WIRE WAS FOUND PEELED OFF AND ENTANGLED WITH THE HIRYU PLUS GUIDE WIRE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. IT WAS INFORMED THAT THERE WAS NO ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640365 ASAHI GLADIUS EX PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AP14R025P 250516A251 04547327133968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown