BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23830092 · Received December 17, 2025

    Report

    Report Number
    3005099803-2025-06752
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 24, 2025
    Report Date
    April 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QXH
    UDI-DI
    08714729904571
    PMA / PMN Number
    K150692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1: INITIAL REPORTER'S ADDRESS:(B)(6) REPORTED HERE AS IT EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF STENT COVER DAMAGED/DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE GALLBLADDER TO FACILITATE DRAINAGE DUE TO INOPERABLE INFLAMMATION OF THE GALLBLADDER DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025, DURING PREPARATION, THE PHYSICIAN NOTICED THAT THERE WERE MANY HOLES IN THE STENT, WHICH COULD NOT BE OPERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273612 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM QXH BOSTON SCIENTIFIC CORPORATION M00553550 0034605388 08714729904571

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male