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

Model Number	M0061921220
Medical Device Problem Codes	Obstruction of Flow (2423); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a1409 captures the reportable event of stent obstruction of flow.
Event or Problem Description
It was reported that during a ureteroscopy intervention procedure, a polaris ultra ureteral stent was intended to be used.During preparation, it was found that the indwelling was unsuccessful and the lumen was blocked.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that during a ureteroscopy intervention procedure, a polaris ultra ureteral stent was intended to be used.During preparation, it was found that the indwelling was unsuccessful and the lumen was blocked.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital (b)(6).Block h6: imdrf device code a1409 captures the reportable event of stent obstruction of flow.Block h11: the complaint device was not returned therefore; product analysis could not be performed.There is no evidence from the manufacturing review to indicate that the device malfunctioned because of a process related defect.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.A risk review was completed and confirmed that the event of "device obstruction within device and device difficult to advance in the anatomy" were defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, an investigation conclusion code of "cause not established" was assigned to this investigation.Correction to field block b1: adverse event/product problem and h6: evaluation method codes.

• 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: 24852615
• Report Number: 2124215-2026-19648
• Device Sequence Number: 5664363
• Product Code: FAD
• UDI-Device Identifier: 08714729124306
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2026

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 Expiration Date: 03/12/2026
• Device Model Number: M0061921220
• Device Catalogue Number: M0061921220
• Device Lot Number: 0031218312
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 04/23/2026; 08/24/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/21/2026; 09/21/2026
• Date Device Manufactured: 03/13/2023
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 169 LB