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

Model Number	M0061921330
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.This event was reported by the distributor.The health care facility is: (b)(6) hospital.Phone: (b)(6).No.(b)(6).
Event or Problem Description
It was reported that a polaris ultra ureteral stent was to be used in a lithotomy procedure.During unpacking, it was found that the stent was fractured.The procedure was completed with another of the same device and there were no patient complications reported.

• Brand Name: POLARIS? ULTRA
• 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: 24880945
• Report Number: 2124215-2026-20269
• Device Sequence Number: 10420692
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: (01)08714729124443(17)280521(10)36586099
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010002
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: M0061921330
• Device Catalogue Number: M0061921330
• Device Lot Number: 0036586099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/18/2026
• Date Device Manufactured: 05/22/2025
• 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