MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS? LOOP; STENT, URETERAL

Model Number	M0061552230
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during preparation for a ureterolithotomy procedure, a polaris ureteral stent was found to be torn, with the stent shaft broken, prior to use.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf code a0401 captures the reportable event of stent shaft break.Block h11: investigation results: the returned polaris loop ureteral stent was analyzed, and during the inspection, the stent was observed to have detached, and both loops were also found to be detached in one section, which confirmed the reported event.The device was inspected under media analysis and magnification, it was possible to see that the stent detached, and both loops also detached in one section.The analysis performed to the returned device; it is possible to conclude that this problem could be caused by operational factors.Risk review: a risk review was completed and confirmed that the event of stent shaft break and stent torn material was defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Device history record (dhr) review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: based on the results of the device evaluation, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that during preparation for a ureterolithotomy procedure, a polaris ureteral stent was found to be torn, with the stent shaft broken, prior to use.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: POLARIS? LOOP
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24260352
• Report Number: 2124215-2026-06439
• Device Sequence Number: 18604594
• Product Code: FAD
• UDI-Device Identifier: 08714729421030
• UDI-Public: (01)08714729421030(17)280306(10)35965840
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061552230
• Device Catalogue Number: M0061552230
• Device Lot Number: 0035965840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown