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

Model Number	M0061921330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Hematuria (2558)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a polaris ultra ureteral stent was implanted into the patient's right ureter during a laser resection of right ureteral lesion via urethra, holmium laser lithotripsy of the right ureteral orifice via urethra, and placement of a right ureteral stent via urethra procedure.Following the procedure, the patient experienced right-side and lower back pain, urinary urgency and recurrent frequent urination.On (b)(6) 2025, the patient was admitted to the hospital, and urinalysis showed hematuria and severe urinary tract infection.A medication of ceftazidime for anti-infection and intravenous fluid support was given to the patient.There were no other patient complications reported.Additional information was received on december 10, 2025, stating that, the onset date of pain, urinary frequency and urgency was on (b)(6) 2025.The stent was removed on (b)(6) 2025, and a new stent of the same model was replaced.The adverse events were reported to have been resolved and the current condition of the patient is stable.There were no issues noted into the device and, in the physician's assessment, pain, urinary frequency and urgency, and uti is not related to the device.
Additional Manufacturer Narrative
Block h6: patient code e1310 captures the reportable event of urinary tract infection.Patient code e2330 captures the reportable event of pain.Patient code e1302 captures the reportable event of hematuria.Patient code e1308 captures the reportable event of urinary frequency.Patient code e1304 captures the reportable event of urinary urgency.Impact code f08 captures the reportable event hospitalization or prolonged hospitalization.Impact code f2303 captures the reportable event of medication required.

• 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: 23840114
• Report Number: 2124215-2025-91759
• Device Sequence Number: 9816721
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M0061921330
• Device Catalogue Number: M0061921330
• Device Lot Number: 0034481362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 07/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male