BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GLADIUS14

    MDR report key: 23188195 · Received October 1, 2025

    Report

    Report Number
    3003775027-2025-00215
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    August 27, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K150445
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. 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 GLADIUS 14 GUIDE WIRE WAS RETURNED FOR EVALUATION WITH THE WIRE TIP MISSING. THE POLYMER JACKET OF THE RETURNED GUIDE WIRE WAS FOUND TORN OFF AT APPROXIMATELY 65MM DISTAL TO THE PROXIMAL SOLDER (SET AT 100MM FROM THE TIP TO FIX THE OUTER COIL ONTO THE CORE WIRE). FROM THE TORN END OF THE POLYMER JACKET, THE OUTER COIL WAS FOUND INTERMITTENTLY ELONGATED DISTALLY FOR APPROXIMATELY 65MM AND THEN FRACTURED. THE CORE WIRE WAS FOUND FRACTURED AT APPROXIMATELY 70MM DISTAL TO THE PROXIMAL SOLDER. THE RETURNED GUIDE WIRE WAS FOUND THREE-DIMENSIONALLY DEFORMED FOR APPROXIMATELY 65MM FROM THE PROXIMAL SOLDER AND HAD MULTIPLE KINKS THROUGHOUT ITS LENGTH. THE SEPARATED WIRE TIP WAS NOT RETURNED. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND THAT THE FRACTURE END OF THE CORE WIRE HAD A FLAT FRACTURE SURFACE WITH CONCENTRIC DIMPLES, INDICATING THAT TORSION HAD MOST LIKELY CONTRIBUTED TO THE CORE WIRE FRACTURE. THE FRACTURE END OF THE OUTER HAD A FLAT FRACTURE SURFACE WITH DIMPLES, INDICATING THAT THE OUTER COIL FRACTURE WAS ATTRIBUTED TO TORSION GENERATED MOST LIKELY WHEN THE COIL WAS PULLED AND STRAIGHTENED. INVESTIGATION OF THE RETURNED GUIDE WIRE SUGGESTED THAT THE CORE WIRE WAS FRACTURED AT APPROXIMATELY 35MM FROM THE TIP DUE TO TORSION WHILE THE OUTER COIL WAS STRETCHED AND THEN FRACTURED AT APPROXIMATELY 30MM FROM THE TIP NEAR THE DISTAL MID SOLDER. THE FRACTURED OUTER COIL WAS DETACHED TOGETHER WITH THE INNER COIL AS WELL AS THE BALL 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 TORSION GENERATED WITH TORQUING MANIPULATION MIGHT HAVE BEEN LOCALLY ACCUMULATED ON THE GLADIUS 14 GUIDE WIRE WHILE THE WIRE TIP WAS CAUGHT DUE TO TORTUOUS VESSEL OR THE LESION, FRACTURING THE CORE WIRE. FURTHER APPLIED TENSILE STRESS GENERATED WITH WIRE REMOVAL THEN CAUSED THE OUTER COIL TO BE DETACHED TOGETHER WITH THE BALL TIP AND THE INNER COIL. ALTHOUGH IT WAS CONCLUDED THAT THE REPORTED EVENT WAS NOT ATTRIBUTED TO THE PRODUCT QUALITY, POSSIBILITY OF WIRE FRAGMENT LEFT IN PATIENT ANATOMY COULD NOT BE ERADICATED. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] OBSERVE GUIDE WIRE MOVEMENT IN THE VESSELS. BEFORE A GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE A 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 GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING WIRE MANIPULATIONS. NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING A GUIDE WIRE AGAINST RESISTANCE MAY CAUSE GUIDE WIRE DAMAGE AND/OR GUIDE WIRE TIP SEPARATION OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE TIP. IF GUIDE WIRE TIP PROLAPSE 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 ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. 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. [MALFUNCTION AND ADVERSE EFFECTS] SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED FOR A 75% OR LESS STENOSIS IN THE POSTERIOR TIBIAL ARTERY / FIBULAR ARTERY. AFTER AN ASAHI GLADIUS GUIDE WIRE WAS INSERTED VIA A 5F UNSPECIFIED ANGIOGRAPHIC CATHETER, THE CATHETER WAS EXCHANGED FOR A 4F NON-ASAHI VERTEBRAL CATHETER. WHEN THE GLADIUS GUIDE WIRE WAS REMOVED FOR ANGIOGRAPHY, THE GUIDE WIRE WAS FOUND DEFECTIVE. THE PROCEDURE WAS THEN CONTINUED WITH ANOTHER DEVICE. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014347 ASAHI GLADIUS14 PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. PPW14R300P 240926A121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other