BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GLADIUS EX

    MDR report key: 24855560 · Received April 13, 2026

    Report

    Report Number
    3003775027-2026-00060
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    4547327133968
    PMA / PMN Number
    K150445
    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 (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: (B)(4). 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 INVESTIGATION. THE RETURNED GLADIUS EX GUIDE WIRE WAS FOUND CURVED FOR APPROXIMATELY 80MM FROM THE TIP. THE POLYMER JACKET WAS FOUND TO BE INTERMITTENTLY SWOLLEN AT APPROXIMATELY 90-130MM FROM THE TIP, WITH PEELING AND TEARING OF THE POLYMER JACKET, WHICH WERE LIKELY DUE TO STRONG ABRASION. 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 PRESSING STRESS MIGHT HAVE BEEN APPLIED ON THE BALLOON CATHETER DUE TO ANATOMICAL AND LESION CONDITIONS, CAUSING THE CATHETER LUMEN TO BE NARROWED. CONSEQUENTLY, THE GLADIUS EX GUIDE WIRE BECAME STUCK WITHIN THE CONCOMITANT BALLOON CATHETER. THE SUBSEQUENT PUSHING AND PULLING MANIPULATION OF THE GUIDE WIRE CAUSED THE POLYMER JACKET TO PEEL AND TEAR. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, THE RETURNED GUIDE WIRE WAS TOO SEVERELY DAMAGED TO COMPLETELY RULE OUT ANY POLYMER JACKET FRAGMENT LEFT IN SITU. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] NEVER USE METALLIC CANNULA OR METALLIC SHEATHS FOR INSERTION AND WITHDRAWAL OF THE GUIDE WIRE. [OTHERWISE, THE SURFACE OF GUIDE WIRE MAY BE DAMAGED SIGNIFICANTLY.]. 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 AN ASAHI GLADIUS EX GUIDE WIRE WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS IN-STENT RE-REOCCLUSION IN SEGMENTS #1-3 OF THE RIGHT CORONARY ARTERY (RCA). AS AN ASAHI CORSAIR PRO MICROCATHETER WAS UNABLE TO BE ADVANCED OVER THE GLADIUS EX GUIDE WIRE, EXCIMER LASER WAS APPLIED TO CANALIZE THE LESION, FOLLOWED BY INFLATION WITH A SMALL SEMI-COMPLIANT BALLOON AND SUBSEQUENT POST-INFLATION WITH A NON-COMPLIANT BALLOON. DURING REMOVAL OF THE NON-COMPLIANT BALLOON, THE NON-COMPLIANT BALLOON BECAME STUCK WITH THE GLADIUS EX GUIDE WIRE. THEREFORE, BOTH DEVICES WERE REMOVED SIMULTANEOUSLY. WHEN THE GLADIUS EX GUIDE WIRE WAS INSPECTED OUTSIDE THE PATIENT ANATOMY, PEELING OF POLYMER JACKET WAS OBSERVED. ANOTHER GUIDE WIRE WAS THEN USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS FINE WITHOUT ANY PROBLEMS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922378 ASAHI GLADIUS EX PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AP14R025P 251111A331 4547327133968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other