BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS (TM) LOOP US W/O SHAFT HOLES

    MDR report key: 25112255 · Received May 7, 2026

    Report

    Report Number
    2124215-2026-24714
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    June 1, 2018
    Report Date
    May 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT EVENT DATE IS UNKNOWN. THE PROVIDED EVENT DATE IS AN APPROXIMATE BASED ON THE RANGE THE PROCEDURES WERE PERFORMED. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. BLOCK H6: IMDRF DEVICE CODE A0104 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. BLOCKS D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A0104 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. LITERATURE SOURCE: LU, Y., HSU, H., HU, S., TZOU. K., CHEN, K., WU C., AND HO, C. COMPLETE INTRAURETERAL STENT PLACEMENT REDUCES STENT-RELATED PAIN IN NORMOTENSIVE SUBJECTS AND IN DIABETES SUBGROUP ANALYSIS OF A PROSPECTIVE RANDOMIZED CLINICAL TRIAL. UROLOGICAL SCIENCE (2024) 35:4. HTTP://DX.DOI.ORG/10.1097/US9.0000000000000032. BLOCK H11: THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED, FOR THIS REASON AND DUE TO THE LACK OF EVIDENCE IS UNABLE TO CONFIRM THE REPORTED EVENT. LABELING REVIEW WAS PERFORMED; IT WAS CONFIRMED THAT THE FOLLOWING ADVERSE EVENTS ARE ANTICIPATED IN THE IFU: PAIN. ALSO, THERE IS NO EVIDENCE THE DEVICE WAS IMPROPERLY USED PER THE IFU, HERE WAS NO EVIDENCE THE DEVICE WAS IMPROPERLY USED AND THERE IS NO EVIDENCE THAT THERE IS ANY ISSUE WITH TRANSLATION WORDING, OR GRAPHICS OF THE IFU/LABELING INFORMATION. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF "STENT MIGRATION AND PAIN" WERE DEFINED IN THE RISK DOCUMENTATION. THESE EVENTS HAVE BEEN ACCOUNTED DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFITS FOR THE PRODUCT. BASED ON THE RESULTS OF THE DEVICE EVALUATION, AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THROUGH AN ARTICLE PUBLISHED IN UROLOGICAL SCIENCE THAT A RANDOMIZED CLINICAL STUDY EVALUATED POSTOPERATIVE OUTCOMES IN PATIENTS WHO RECEIVED THE POLARIS LOOP URETERAL STENT FOLLOWING URETEROSCOPIC LITHOTRIPSY. THE PUBLICATION DESCRIBED TWO STENT PLACEMENT METHODS: COMPLETE INTRAURETERAL STENT PLACEMENT (CIU SP) AND CONVENTIONAL STENT PLACEMENT (C SP). ACCORDING TO THE ARTICLE, BETWEEN JUNE 2018 AND MAY 2020, 103 PATIENTS WERE RANDOMIZED TO THE CIU SP (N=53) AND C SP (N=50) GROUPS. TWELVE PATIENTS WERE EXCLUDED DUE TO THE NEED FOR EXTENDED INDWELLING STENT DURATION. THE FINAL ANALYSIS INCLUDED 91 PATIENTS (CIU SP N=45; C SP N=46). THE ARTICLE REPORTED THAT STENT ASSOCIATED BODY PAIN OCCURRED MORE FREQUENTLY IN THE C SP GROUP. SPECIFICALLY, 41 PATIENTS IN THE C SP GROUP REPORTED BODY PAIN COMPARED WITH 31 PATIENTS IN THE CIU SP GROUP (P = 0.021). THE AUTHORS CONCLUDED THAT CIU SP SIGNIFICANTLY REDUCED STENT RELATED PAIN ON POSTOPERATIVE DAY 7, WITH A MORE PRONOUNCED EFFECT AMONG NORMOTENSIVE INDIVIDUALS AND PATIENTS WITH DIABETES. THE PUBLICATION ALSO NOTED THAT STENTS IN THE CIU SP GROUP HAD MIGRATED TO THE URINARY BLADDER; HOWEVER, THE AUTHORS STATED THAT THIS MIGRATION WAS UNLIKELY TO AFFECT THE STUDY CONCLUSIONS AND MIGHT UNDERESTIMATE THE DIFFERENCE BETWEEN THE TWO PLACEMENT METHODS. THE STUDY DEMONSTRATED THE EFFICACY OF CIU SP IN SIGNIFICANTLY ALLEVIATING STENT-ASSOCIATED PAIN WHEN COMPARED WITH THE PAIN OUTCOMES OF C SP. THE FINDINGS HIGHLIGHTED THE POTENTIAL ADVANTAGES OF CIU-SP STRATEGIES, ESPECIALLY IN IMPROVING THE POSTOPERATIVE EXPERIENCE OF INDIVIDUALS WITH NORMOTENSION OR DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8832 POLARIS (TM) LOOP US W/O SHAFT HOLES STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown