BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS SD RENAL/BILIARY

    MDR report key: 23783444 · Received December 11, 2025

    Report

    Report Number
    2124215-2025-90467
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 13, 2025
    Report Date
    January 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729390527
    PMA / PMN Number
    K152607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. DEVICE EVALUATED BY MFR: THE EXPRESS SD WAS RETURNED FOR ANALYSIS. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED THAT THE GUIDEWIRE LUMEN IS SEPARATED 9CM FROM THE TIP. THE INFLATION LUMEN IS SEPARATED 9.3CM FROM THE TIP. THE INFLATION LUMEN IS STRETCHED 69.2CM FROM THE HUB. THERE ARE MULTIPLE KINKS ON THE SHAFT IN THE STRETCHED SECTION. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS CONFIRMED THERE IS DAMAGE TO THE DEVICE.

    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 FAILURE TO DEFLATE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERIOR MESENTERIC ARTERY (SMA). A 7.0MM X 19MM X 90CM EXPRESS SD RENAL/BILIARY WAS SELECTED FOR USE. DURING THE PROCEDURE, A 6F GUIDE CATHETER AND A .14 GUIDEWIRE WERE INSERTED INTO THE ARTERY. THE EXPRESS STENT WAS ADVANCED INTO THE SMA AND THE GUIDE SHEATH WAS RETRACTED BACK. THE BALLOON WAS INFLATED TO NOMINAL PRESSURE AND COMPLETELY DEFLATED AFTER THREE MINUTES. DURING AN ATTEMPT TO REMOVE THE BALLOON, RESISTANCE WAS MET. FORCE WAS APPLIED, CAUSING THE BALLOON SHAFT TO BREAK. THE BALLOON AND SHAFT WERE SUCCESSFULLY RETRIEVED OUT OF THE SHEATH WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FAILURE TO DEFLATE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERIOR MESENTERIC ARTERY (SMA). A 7.0 MM X 19 MM X 90 CM EXPRESS SD RENAL/BILIARY WAS SELECTED FOR USE. DURING THE PROCEDURE, A 6F GUIDE CATHETER AND A .14 GUIDEWIRE WERE INSERTED INTO THE ARTERY. THE EXPRESS STENT WAS ADVANCED INTO THE SMA AND THE GUIDE SHEATH WAS RETRACTED BACK. THE BALLOON WAS INFLATED TO NOMINAL PRESSURE AND COMPLETELY DEFLATED AFTER THREE MINUTES. DURING AN ATTEMPT TO REMOVE THE BALLOON, RESISTANCE WAS MET. FORCE WAS APPLIED, CAUSING THE BALLOON SHAFT TO BREAK. THE BALLOON AND SHAFT WERE SUCCESSFULLY RETRIEVED OUT OF THE SHEATH WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2345282 EXPRESS SD RENAL/BILIARY STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74937912719900 0036625193 08714729390527

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown