BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 22893779 · Received August 26, 2025

    Report

    Report Number
    2124215-2025-58513
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    July 21, 2025
    Report Date
    September 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    UDI-DI
    08714729058533
    PMA / PMN Number
    K974541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED. BLOCK B2, BLOCK B5, BLOCK D6A, BLOCK D6B, BLOCK E1, AND BLOCK E3, HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON AUGUST 24, 2025.

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS IMPLANTED INTO THE PATIENT. A MONTH LATER, FOLLOWING THE PROCEDURE, A STENT REMOVAL PROCEDURE WAS PERFORMED, AND IT WAS FOUND THAT THE STENT'S WALL WAS ENCRUSTED BUT WAS STILL ABLE TO DRAIN. THE STENT WAS COMPLETELY REMOVED UNDER INTRAVENOUS ANESTHESIA AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO NEW STENT IMPLANTED AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS IMPLANTED INTO THE PATIENT. A MONTH LATER, FOLLOWING THE PROCEDURE, A STENT REMOVAL PROCEDURE WAS PERFORMED, AND IT WAS FOUND THAT THE STENT'S WALL WAS ENCRUSTED. THE STENT WAS REMOVED UNDER INTRAVENOUS ANESTHESIA AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630731 CONTOUR STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M0061802230 0035615195 08714729058533

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female