BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS LOOP

    MDR report key: 22731262 · Received August 6, 2025

    Report

    Report Number
    2124215-2025-54190
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    June 19, 2025
    Report Date
    September 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED. IMDRF F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER, HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025. IMDRF DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED. IMDRF F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DUE TO CLEAR DIAGNOSIS OF THE LEFT URETERAL CALCULI, LITHOTRIPSY WAS NOT SUITABLE DURING PREGNANCY. THE TRANSURETHRAL LEFT URETERAL STENT PLACEMENT WAS PERFORMED UNDER LOCAL ANESTHESIA. THE PACKAGE INDICATED THAT THE STENT COULD BE PLACED FOR HALF A YEAR. THE URETERAL STENT REPLACEMENT WAS PERFORMED UNDER INTRAVENOUS ANESTHESIA. DURING THE PROCEDURE, MULTIPLE CALCULI WERE OBSERVED ADHERING TO THE UPPER AND LOWER SEGMENTS OF THE DOUBLE-J CATHETER. THE PATIENT WAS GIVEN TRANSURETHRAL BLADDER LASER LITHOTRIPSY COMBINED WITH TRANSURETHRAL URETEROSCOPIC URETER LASER LITHOTRIPSY, AND THE POSTOPERATIVE RECOVERY WAS GOOD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DUE TO CLEAR DIAGNOSIS OF THE LEFT URETERAL CALCULI, LITHOTRIPSY WAS NOT SUITABLE DURING PREGNANCY. THE TRANSURETHRAL LEFT URETERAL STENT PLACEMENT WAS PERFORMED UNDER LOCAL ANESTHESIA. THE PACKAGE INDICATED THAT THE STENT COULD BE PLACED FOR HALF A YEAR. THE URETERAL STENT REPLACEMENT WAS PERFORMED UNDER INTRAVENOUS ANESTHESIA. DURING THE PROCEDURE, MULTIPLE CALCULI WERE OBSERVED ADHERING TO THE UPPER AND LOWER SEGMENTS OF THE DOUBLE-J CATHETER. THE PATIENT WAS GIVEN TRANSURETHRAL BLADDER LASER LITHOTRIPSY COMBINED WITH TRANSURETHRAL URETEROSCOPIC URETER LASER LITHOTRIPSY, AND THE POSTOPERATIVE RECOVERY WAS GOOD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288657 POLARIS LOOP STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M0061552320 0030515020

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention