BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GAIA NEXT 2

    MDR report key: 18263828 · Received December 4, 2023

    Report

    Report Number
    3003775027-2023-00124
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    November 1, 2023
    Report Date
    July 19, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327112918
    PMA / PMN Number
    K192599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 1:27 AM AT OUR END. FROM (B)(6), MDR DATA SYSTEMS TEAM, TO INFORM US OF THE DISCREPANCIES IN THE DEVICE IDENTIFICATION FIELDS OF OUR SUBMITTED ELECTRONIC EQUIVALENT OF THE FDA FORM 3500A. WHEN COMPARED WITH THE INFORMATION 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 GAIA NEXT 2 TO ASAHI GAIA NEXT 2. D3: MANUFACTURER NAME, CITY AND STATE: FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL #: FROM NO ENTRY TO AH14R020P. CATALOG #: FROM AH14R020P TO NO ENTRY. G1: CONTACT OFFICE: FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. H4: DEVICE MANUFACTURE DATE: FROM 24-7-2023 TO NO ENTRY.

    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 BY THE USER FACILITY. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. ALL THE SHIPPED GUIDE WIRES ARE INSPECTED IN THE PRODUCTION PROCESS FOR NO ANOMALY IN PRODUCT QUALITY INCLUDING TIP LOAD. BASED ON THE OBTAINED INFORMATION, RESULTS OF LOT HISTORY RECORDS REVIEW, AND REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT THE GUIDE WIRE MIGHT HAVE BEEN FORCIBLY PUSHED AGAINST THE VESSEL WALL DUE TO THE FORCE GENERATED WHEN THE GUIDE WIRE WAS ADVANCED TO CROSS THE LESION OR DURING THE DELIVERY OF THE CONCOMITANTLY USED DEVICE, CAUSING VESSEL PERFORATION. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED 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. [MALFUNCTION AND ADVERSE EFFECTS] DAMAGE TO A VESSEL, INCLUDING POSSIBLE VESSEL PERFORATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASAHI GAIA NEXT 2 GUIDE WIRE AND AN ASAHI FIELDER XT-R GUIDE WIRE WERE USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE SEGMENT #7 OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN UNSPECIFIED GUIDE WIRE WAS ADVANCED INTO THE LAD AND INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THE OSTIUM OF THE SEGMENT #9. WHEN GUIDE WIRE ENTRY TO THE SEGMENT #9 WAS ATTEMPTED, VESSEL PERFORATION OCCURRED. SEVERAL GUIDE WIRES WERE USED FOR ENTRY AND THE VESSEL PERFORATION OCCURRED LIKELY DURING THE USE OF THE GAIA NEXT 2 GUIDE WIRE OR THE FIELDER XT-R GUIDE WIRE. HEMOSTASIS WITH PROTAMINE INJECTION AND DILATATION WITH A NON-ASAHI BALLOON CATHETER WERE ATTEMPTED BUT FAILED. EVENTUALLY, HEMOSTASIS WAS ACHIEVED BY DEPLOYING A NON-ASAHI COVERED STENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW ACHIEVED BY STENTING. IT WAS INFORMED THAT THE PATIENT WAS DISCHARGED AS SCHEDULED THE DAY AFTER THE PROCEDURE. GAIA NEXT 2 GUIDE WIRE: MFR REPORT #: 3003775027-2023-00124. FIELDER XT-R GUIDE WIRE: MFR REPORT #: 3003775027-2023-00125.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122740 ASAHI GAIA NEXT 2 PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. AH14R020P 230717A301 04547327112918

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention