BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GLADIUS MONGO14

    MDR report key: 17910388 · Received October 11, 2023

    Report

    Report Number
    3003775027-2023-00097
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    September 15, 2023
    Report Date
    July 18, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327123686
    PMA / PMN Number
    K180784
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. AS WE RECEIVED AN EMAIL TIME-STAMPED SATURDAY, JULY 6, 2024 2:07 AM AT OUR END FROM MS. (B)(6), MDR DATA SYSTEMS TEAM, TO INFORM US OF THE DISCREPANCIES BETWEEN THE DEVICE IDENTIFICATION FIELDS OF THE ELECTRONIC EQUIVALENT OF THE FDA FORM 3500A THAT WE HAD SUBMITTED COMPARED TO THE INFORMATION INCLUDED FOR THE CORRESPONDING FIELDS IN THE GUDID. AFTER COMPARING THE INFORMATION IN THE PREVIOUS SUBMITTED MDR WITH THAT IN THE CORRESPONDING FIELDS IN THE GUDID, WE DETERMINED TO SUBMIT THIS SUPPLEMENTAL REPORT. THE CHANGES WE INTEND TO MAKE ARE AS FOLLOWS: D1: BRAND NAME - FROM GLADIUS MONGO 14 TO ASAHI GLADIUS MONGO14. D3: MANUFACTURER NAME, CITY, AND STATE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL # - FROM NO ENTRY TO AP14R023S. CATALOG # - FROM AP14R023S TO NO ENTRY. G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. H4: DEVICE MANUFACTURE DATE - FROM 05-4-2023 TO NO ENTRY.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. A GLADIUS MONGO 14 WAS RETURNED FOR INVESTIGATION. THE POLYMER JACKET OF THE RETURNED GLADIUS MONGO 14 WAS FOUND TWISTED AND TORN AT APPROXIMATELY 77MM DISTAL TO THE PROXIMAL SOLDER (SET AT 85MM FROM THE TIP FOR THE PURPOSE OF FIXING THE OUTER COIL ONTO THE INNER CORE), WHERE THE INNER COIL AND CORE WIRE WERE TWISTED TOGETHER WITH THE OUTER COIL, TIGHTENED, AND FRACTURED. THESE FINDINGS SUGGESTED THAT THE GLADIUS MONGO 14 WAS FRACTURED AT APPROXIMATELY 8MM FROM ITS 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 WITH GUIDE WIRE MANIPULATION WAS LOCALLY ACCUMULATED ON THE SUBJECT SEGMENT WHEN THE TIP OF THE GLADIUS MONGO 14 WAS CAUGHT IN THE OCCLUDED SEGMENT OF THE SVG. CONSEQUENTLY, THE TIP WAS TWISTED AND TORN. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. NO CAPA WILL BE TAKEN. THE 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 EFFECTS] SEPARATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI GLADIUS MONGO 14 GUIDE WIRE WAS USED TO BE ANTEGRADELY ADVANCED TO A HEAVILY CALCIFIED CTO IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI). AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS, THE PHYSICIAN DECIDED TO CHANGE THE ACCESS ROUTE TO BY WAY OF THE SAPHENOUS VEIN GRAFT (SVG). AFTER SEVERAL ATTEMPTS TO PUSH THE GLADIUS MONGO 14 IN THE OCCLUDED SVG, THE TIP SEGMENT OF THE GUIDE WIRE WAS DETACHED IN 2 MINUTES AND LEFT IN THE OCCLUDED SVG. AS THE PHYSICIAN DECIDED TO MAKE NO ATTEMPTS TO RETRIEVE THE DETACHED TIP, CONSERVATIVE TREATMENT WAS CHOSEN AND THE PROCEDURE WAS TERMINATED. IT WAS INFORMED THAT HERE WERE NO HAZARDOUS PATIENT EFFECTS SUCH AS COMPLICATIONS AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180285 ASAHI GLADIUS MONGO14 PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AP14R023S 230330A051 04547327123686

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Disability