BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR VL?

    MDR report key: 22549719 · Received July 18, 2025

    Report

    Report Number
    2124215-2025-47867
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 26, 2025
    Report Date
    October 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    PMA / PMN Number
    K974541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED. INVESTIGATION ANALYSIS: UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS CONTOUR URETERAL STENT UNDERWENT A THOROUGH ANALYSIS. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS CALCIFIED. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED EVENT IS AN ANTICIPATED RISK AND IS A POTENTIAL COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE. A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    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 IN A PATIENT AFTER URETERORENOSCOPY WAS PERFORMED. POST PROCEDURE, IT WAS FOUND THAT THE STENT WAS ENCRUSTED AFTER A SHORT TIME. STENT WAS REMOVED AND WAS REPLACED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS IMPLANTED IN A PATIENT AFTER URETERORENOSCOPY WAS PERFORMED. POST PROCEDURE, IT WAS FOUND THAT THE STENT WAS ENCRUSTED AFTER A SHORT TIME. STENT WAS REMOVED AND WAS REPLACED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295186 CONTOUR VL? STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M0061801550 0031769192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown