BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GLADIUS MONGO14 ES

    MDR report key: 24824752 · Received April 9, 2026

    Report

    Report Number
    3003775027-2026-00058
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 9, 2026
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    94547327123747
    PMA / PMN Number
    K180784
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS DISCARDED AT THE USER FACILITY AND NOT RETURNED. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED CASE. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. AS THE AFFECTED DEVICE WAS NOT RETURNED, THE CAUSE OF THIS EVENT COULD NOT BE IDENTIFIED. BASED ON THE OBTAINED INFORMATION AND REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT ABRASION MIGHT HAVE BEEN APPLIED ON THE SUBJECT SEGMENT OF THE GLADIUS MONGO 14 ES GUIDE WIRE DUE TO THE INTERFERENCE WITH THE CONCOMITANT ATHERECTOMY CATHETER WHEN DELIVERING THE CATHETER AND/OR PUSHING-PULLING THE GUIDE WIRE. CONSEQUENTLY, THE POLYMER JACKET WAS TORN OFF AND RESISTANCE WOULD INCREASE BETWEEN THE GUIDE WIRE AND CONCOMITANT CATHETER. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, IT WAS UNABLE TO COMPLETELY RULE OUT THAT FRAGMENTED POLYMER JACKET WAS LEFT IN THE PATIENT ANATOMY BECAUSE THE DEVICE WAS NOT RETURNED. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS]: ~ DO NOT USE THIS GUIDE WIRE IN COMBINATION WITH CATHETERS (ATHERECTOMY CATHETER, METALLIC DILATOR ETC.) WHICH METALLIC PARTS MAY CONTACT SURFACE OF THIS GUIDE WIRE. OTHERWISE, THIS GUIDE WIRE MAY BE DAMAGED OR BREAK APART. ~ 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. ~ 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. [MALFUNCTION AND ADVERSE EFFECTS] ~ ABRASION OF THE GUIDE WIRE COATING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI GLADIUS MONGO 14 ES GUIDE WIRE WAS USED FOR AN ATHERECTOMY TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND TIBIAL ARTERY. WHEN USING AN AURYON LASER ATHERECTOMY SYSTEM CATHETER, THE COATING OF THE GLADIUS MONGO 14 ES GUIDE WIRE WAS PEELED OFF, WHICH MADE THE CATHETER STICK TO THE WIRE. THE GLADIUS MONGO 14 ES GUIDE WIRE AND THE CATHETER WERE REMOVED AND OTHER GUIDE WIRES WERE USED. IT WAS INFORMED THAT THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886775 ASAHI GLADIUS MONGO14 ES PERIPHERAL VASCULAR GUIDE WIRE DQX ASAHI INTECC CO., LTD. AP14R324S 260106A251 94547327123747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other