BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23767282 · Received December 10, 2025

    Report

    Report Number
    3005099803-2025-06610
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    November 9, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QXH
    UDI-DI
    08714729904540
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E1032 CAPTURES THE REPORTABLE EVENT OF VOMITING. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION FOR EPIGASTRIC PAIN. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF THE ANALGESIC ADMINISTERED. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF THE ABDOMIN-PELVIC CT SCAN PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TO TREAT A MALIGNANT BILIARY OBSTRUCTION THROUGH A BILIARY DRAINAGE, DURING AN ENDOSCOPIC ULTRASOUND (EUS) GUIDED BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. THREE DAYS AFTER THE STENT PLACEMENT PROCEDURE, ON (B)(6) 2025, THE PATIENT WAS HOSPITALIZED FOR EPIGASTRIC PAIN AND VOMITING. AN ABDOMIN-PELVIC CT SCAN WAS PERFORMED ON (B)(6) 2025, AND AN ANALGESIC WAS ADMINISTERED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2878176 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM QXH BOSTON SCIENTIFIC CORPORATION M00553520 0037558499 08714729904540

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Hospitalization