BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS ULTRA

    MDR report key: 18379516 · Received December 21, 2023

    Report

    Report Number
    2124215-2023-72031
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 1, 2023
    Report Date
    December 21, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    UDI-DI
    08714729124443
    PMA / PMN Number
    K010002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4, H4: THE REPORTED LOT NUMBER 3223405 DOES NOT PROVIDE A MATCH IN THE SYSTEM SEARCH; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.

    Description of Event or Problem · 0

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO URETERAL POLARIS ULTRA STENTS WERE ATTEMPTED TO BE USED DURING A STENT PLACEMENT PROCEDURE FOR KIDNEY STONE MANAGEMENT. THE EXACT EVENT DATE WAS UNKNOWN. DURING UNPACKING, IT WAS FOUND THAT THE TWO STENTS WERE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS ULTRA STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297611 POLARIS ULTRA STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M0061921330 08714729124443

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown