BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-TREME XT-R

    MDR report key: 18263827 · Received December 4, 2023

    Report

    Report Number
    3003775027-2023-00125
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    November 1, 2023
    Report Date
    July 22, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K171933
    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, (B)(6) 2024 9:54 AM AT OUR END FROM (B)(6), MDR DATA SYSTEMS TEAM, TO INFORM US THAT INFORMATION ABOUT THE SUSPECT MEDICAL DEVICES INVOLVED IN THE REPORTED EVENTS, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A WAS MISSING. THE SUBJECT DEVICE WAS INITIALLY REPORTED AS X-TREME XT-R WHICH IS DISTRIBUTED AS FIELDER XT-R IN THE US; THEREFORE, BRAND NAME IN BLOCK D1 WAS CHANGED FROM FIELDER XT-R TO X-TREME XT-R AS INDICATED IN THE PACKAGE LABEL OF THE SUBJECT DEVICE. AFTER COMPARING THE INFORMATION IN THE PREVIOUS SUBMITTED MDR WITH THAT OF FIELDER XT-R IN THE CORRESPONDING FIELDS IN THE GUDID, WE DETERMINED TO SUBMIT THIS SUPPLEMENTAL REPORT. THE CHANGES WE INTEND TO MAKE ARE AS FOLLOWS: D3: MANUFACTURER NAME, CITY, AND STATE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL # - FROM NA TO R0419-Z6PSR CATALOG # - FROM R0419-Z6PSR TO NO ENTRY SERIAL # - FROM NA TO NO ENTRY PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # - FROM UNKNOWN TO NO ENTRY G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. EMAIL - FROM [email protected] TO [email protected] AS LOT INFORMATION WAS UNAVAILABLE, THE PRODUCT LABEL INCLUDED IN THE PRODUCTION RECORD, WHICH IS LINKED TO THE LOT INFORMATION, COULD NOT BE CONFIRMED. THEREFORE, THE UNIQUE DEVICE IDENTIFIER (UDI) # AS WELL AS EXPIRATION DATE COULD NOT BE OBTAINED.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE IDENTIFIED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS DISCARDED BY THE USER FACILITY. LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED BECAUSE LOT INFORMATION WAS UNAVAILABLE. ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS AND SATISFIED THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA; THEREFORE, IT WAS CONCLUDED THAT THERE WAS NO ANOMALY IN PRODUCT QUALITY. 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
    2122739 X-TREME XT-R PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. R0419-Z6PSR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention