MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS ULTRA; STENT, URETERAL

Model Number	M0061921350
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion, the physician attempted to place each polaris ultra ureteral stent, but the coil tip was crumpled and malformed.The third stent attempted and completed with insertion just fine.Two separate lots, with the same issue.There were no patient complications reported.
Additional Manufacturer Narrative
H6: imdrf device code a0406 captures the reportable event of stent material deformation, inside the patient.Imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.Note: this report is two of two complaints that pertain to the same event (mfr report# 2124215-2025-56436 and mfr.Report # 2124215-2025-56437).
Additional Manufacturer Narrative
Imdrf device code a0406 captures the reportable event of stent material deformation, inside the patient.Imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.The polaris ultra ureteral stent coil was clarified to be deformed and kinked.Additional information was received (b)(6) 2025 confirming that the event occured outside the patient.Although this can result in a clinically insignificant delay of the procedure, this event is unlikely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, boston scientific no longer considers this to be a reportable event.Note: this report is two of two complaints that pertain to the same event (mfr report# 2124215-2025-56436 and mfr.Report # 2124215-2025-56437).
Event or Problem Description
It was reported that during insertion, the physician attempted to place each polaris ultra ureteral stent, but the coil tip was crumpled and malformed.The third stent attempted and completed with insertion just fine.Two separate lots, with the same issue.There were no patient complications reported.

• 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: 22829624
• Report Number: 2124215-2025-56437
• Device Sequence Number: 9458184
• Product Code: FAD
• UDI-Device Identifier: 08714729124498
• UDI-Public: (01)08714729124498(17)261105(10)32790304
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: M0061921350
• Device Catalogue Number: M0061921350
• Device Lot Number: 0032790304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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 Sex: Unknown