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

Model Number	M0061921230
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	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a polaris ultra ureteral stent was to be used in a lithotripsy 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.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was to be used in a lithotripsy 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.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.Correction to block h6 device code.Block h11: investigation analysis the device was not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.It was 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 shaft break and coil detachment of device or device component was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit 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.

• 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: 50684087
• Report Number: 2124215-2026-48076
• Device Sequence Number: 5155688
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: (01)08714729124320(17)271002(10)34979139
• 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
• Report Date (Section B): 09/29/2026

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: M0061921230
• Device Catalogue Number: M0061921230
• Device Lot Number: 0034979139
• 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: 08/14/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 10/02/2024
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 154 LB