BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE

    MDR report key: 25119838 · Received May 7, 2026

    Report

    Report Number
    9681834-2026-00103
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 7, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    UDI-DI
    04987350773630
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    . A4: WEIGHT: 76.2KG . HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER - NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. - NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PLEASE REFER TO SECTION H10 FOR THE RELATED IMPORTER REPORT NUMBER. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR PERCUTANEOUS BILIARY DRAIN PLACEMENT. WHILE NAVIGATING COMMON BILE DUCT, A PIECE OF STIFF GLIDEWIRE BROKE OFF AND IS IN THE HILUM OF LIVER. THE FRAGMENT HAS NOT BEEN REMOVED FROM THE BODY. THE ESTIMATED BLOOD LOSS IS LESS THAN 5ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221975 GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA GS3508 251020 04987350773630

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other