BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS SD RENAL/BILIARY

    MDR report key: 25166443 · Received May 13, 2026

    Report

    Report Number
    2124215-2026-26018
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729484844
    PMA / PMN Number
    K152607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): FGE, NIN. G4 - PREMARKET / 510(K) #: K152607, K162404, P060006.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 76% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RENAL ARTERY. A 6.0MM X 18MM X 150CM EXPRESS SD RENAL/BILIARY STENT BALLOON EXPANDABLE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE EXPRESS SD RENAL/BILIARY DEVICE WAS DIFFICULT TO LOAD ONTO THE 0.014" NON-BOSTON SCIENTIFIC GUIDEWIRE AND COULD NOT BE FULLY ADVANCED THROUGH THE MACH 1 GUIDE CATHETER. THE EXPRESS SD RENAL/BILIARY BECAME STUCK ON THE GUIDEWIRE, REQUIRING BOTH DEVICES TO BE REMOVED SIMULTANEOUSLY. THE RENAL ARTERY WAS THEN RE-WIRED, AND THE PHYSICIAN ELECTED TO BALLOON THE LESION WITH A STERLING BALLOON TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152478 EXPRESS SD RENAL/BILIARY STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74937912618150 0033233665 08714729484844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown