BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS SD RENAL/BILIARY

    MDR report key: 22955330 · Received September 3, 2025

    Report

    Report Number
    2124215-2025-60660
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    July 18, 2025
    Report Date
    October 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729390473
    PMA / PMN Number
    K152607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): FGE, NIN G4 - PREMARKET / 510(K) #: K152607, K162404, P060006 DEVICE EVALUATED BY MFR: THE EXPRESS SD DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. THE OUTER SHAFT, INNER SHAFT, BALLOON, AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED THAT THERE WERE MULTIPLE KINKS ALONG THE SHAFT. IT WAS ALSO NOTED THAT THE DEVICE WAS IN TWO PIECES AND THAT THE STENT WAS BENT AND DAMAGED ON THE BALLOON. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THIS CONCLUDES THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED PULMONARY VESSEL. A 5.0MMX19MMX150CM EXPRESS SD STENT BALLOON EXPANDABLE WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, THE SHAFT OF THE STENT WAS SNAPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED PULMONARY VESSEL. A 5.0MMX19MMX150CM EXPRESS SD STENT BALLOON EXPANDABLE WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, THE SHAFT OF THE STENT WAS SNAPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450742 EXPRESS SD RENAL/BILIARY STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74937912519150 0033908946 08714729390473

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Female