BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS SD RENAL/BILIARY

    MDR report key: 21207957 · Received January 22, 2025

    Report

    Report Number
    2124215-2025-02843
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 18, 2024
    Report Date
    April 25, 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): NIN. G4 - PREMARKET / 510(K) #: K152607, K162404, P060006. DEVICE EVALUATED BY MFR: THE EXPRESS SD BALLOON CATHETER 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 THE STENT IS PARTIALLY DEPLOYED. MICROSCOPIC EXAMINATION REVEALED NO ADDITIONAL DAMAGES. THERE IS CONTRAST PRESENT INSIDE THE INFLATION LUMEN. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS FOUND THAT THE STENT IS PARTIALLY DEPLOYED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 5.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS USED IN THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 5.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS USED IN THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572728 EXPRESS SD RENAL/BILIARY STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74937912519150 0031366739 08714729390473

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male