BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS LOOP

    MDR report key: 15908667 · Received December 2, 2022

    Report

    Report Number
    3005099803-2022-07044
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    August 11, 2022
    Report Date
    December 2, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    UDI-DI
    08714729421085
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETERAL STENT REPLACEMENT PROCEDURE IN THE KIDNEY, URETER AND BLADDER PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, IT WAS NOTED THAT THE PATIENT HAD A FOLLOW UP APPOINTMENT, AND IT WAS FOUND THAT THE KIDNEY, URETER AND BLADDER SHOW HYDRONEPHROSIS. IT WAS REPORTED THAT AFTER THE LITHOTRIPSY TREATMENT, THE LITTLE CRUSHED STONE WAS SUPPOSED TO DRAINED THROUGH STENT OR URINE, BUT THE STONE CANT PASS THROUGH THE AND BLOCKED AT THE END OF THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER POLARIS LOOP URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348741 POLARIS LOOP STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M0061552320 0028832694 08714729421085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown