MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Polaris? Ultra; stent, ureteral

Model Number	M006192133090
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a flexible ureteroscopy procedure in the kidney.During insertion, the stent would not advance through the guidewire, and it was noticed that the stent was crumpled.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block e1: initial reporter address 1 and 2; (b)(6) block h6: device code a040601 captures the reportable event of stent buckled material inside the patient.

• 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: 50856103
• Report Number: 2124215-2026-50437
• Device Sequence Number: 10025941
• Product Code: FAD
• UDI-Device Identifier: 08714729124450
• Combination Product (Y/N): N
• Initial Reporter Country: PR
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: M006192133090
• Device Catalogue Number: M006192133090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/22/2026
• 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