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

Model Number	M0061921240
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	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material inside the patient.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a ureteroscopy procedure in the kidney.During the procedure, the stent was not going over the wire and it was noticed that it was buckling at the ureteral opening.The procedure was completed with another stent and there were no patient complications reported.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a ureteroscopy procedure in the kidney.During the procedure, the stent was not going over the wire and it was noticed that it was buckling at the ureteral opening.The procedure was completed with another stent and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material inside the patient.Block h11: investigation analysis the device was discarded; therefore, a technical analysis could not be performed.A review of the device history record (dhr) confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of stent/delivery system difficult to advance and stent buckled/accordion were defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Correction to block 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: 24868488
• Report Number: 2124215-2026-20016
• Device Sequence Number: 9899656
• Product Code: FAD
• UDI-Device Identifier: 08714729124344
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2026

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: M0061921240
• Device Catalogue Number: M0061921240
• Device Lot Number: 0037312115
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/27/2026; 08/21/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/22/2026; 09/16/2026
• Date Device Manufactured: 08/27/2025
• 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