BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE WIRE M

    MDR report key: 22327746 · Received June 25, 2025

    Report

    Report Number
    9681834-2025-00110
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 25, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED . A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED . A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED . D4: LOT NUMBER: REQUESTED, UNKNOWN. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER . D4: UDI: N/A AT THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: 510K NUMBER: K923607, K926214. H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. SINCE THE ACTUAL DEVICE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. IN THE PAST TWO YEARS, WE HAVE NOT RECEIVED ANY SIMILAR COMPLAINTS OF THE INVOLVED PRODUCTS CAUSED BY THE MANUFACTURING PROCESS. (CAUSE OF OCCURRENCE/CONCLUSION) SINCE THE LOT# WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL DEVICE COULD NOT BE INVESTIGATED. IN ADDITION, SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL. A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THIS WIRE FOR INITIAL PLACEMENT. " TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE COATING OF THE GUIDEWIRE (MODEL: RFGS35153M) WAS FOUND TO BE RETAINED WITHIN THE PATIENT'S KIDNEY BASED ON POST-OPERATIVE X-RAY FINDINGS. IN PERCUTANEOUS NEPHROLITHOTOMY (PCNL) FOR FULL STAGHORN STONE, AFTER NEEDLE PUNCTURE, THE TERUMO GUIDEWIRE WAS INSERTED FOR PCNL TRACT CREATION. IN VIEW OF FULL STAGHORN STONE AND LIMITED SPACE BETWEEN STONE AND COLLECTING SYSTEM, THE GUIDEWIRE WAS MANIPULATED SEVERAL TIMES WITHIN METAL NEEDLE BEFORE ABLE TO COIL AROUND STONE. THE EMS SWISS LITHOCLAST TRILOGY WAS APPLIED IN THE VICINITY OF THE GUIDEWIRE DURING THE PROCEDURE, AND THE METAL NEEDLE USED WAS A CHIBA BIOPSY NEEDLE (18G × 20CM, ARGON MEDICAL DEVICES). THE COATING OF THE GUIDEWIRE WAS FOUND TO BE RETAINED WITHIN THE PATIENT'S KIDNEY. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130953 GUIDE WIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF*GS35153M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O CHIBA BIOPSY NEEDLE (18G X 20CM, ARGON MEDICAL)| EMS SWISS LITHOCLAST TRILOGY