BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC BILIARY STENT

    MDR report key: 23705516 · Received December 3, 2025

    Report

    Report Number
    MW5179803
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 20, 2025
    Report Date
    November 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC STENT 10 X 60 FULLY COVERED METAL STENT UNABLE TO BE DEPLOYED AS WIRE COULD NOT BE PUT THROUGH STENT ONCE PACKAGE OPENED. LOT# 3737448, EXP: 09/02/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2808036 BOSTON SCIENTIFIC BILIARY STENT BILIARY STENT SYSTEM FOR BENIGN STRICTURES PNB BOSTON SCIENTIFIC CORPORATION M00570370 37374448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown