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

Model Number	M0061921330
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	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a04 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 transurethral stent placement procedure.During the procedure, the front-end coil rolled up and could not advance any further.The procedure was completed with another same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a04 captures the reportable event of stent buckled material inside the patient.Block h11: upon receipt at our quality assurance laboratory, this polaris ultra ureteral stent underwent a thorough analysis.Visual analysis did not identify any damages to the returned device.Functional evaluation revealed that it "passed" when a mandrel of 0.039 was inserted into the stent to evaluate if some resistance is felt inside the device, however, no resistance was felt during the analysis performed and the mandrel was able to fully pass through the stent.The pouch and the suture were not returned.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.Based on the information available, media, and analysis results, it was not possible to identify any evidence of either the alleged issues or any defect on the device.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a transurethral stent placement procedure.During the procedure, the front-end coil rolled up and could not advance any further.The procedure was completed with another same device and 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: 22424285
• Report Number: 2124215-2025-44263
• Device Sequence Number: 18149000
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: (01)08714729124443(17)270308(10)33588663
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: M0061921330
• Device Catalogue Number: M0061921330
• Device Lot Number: 0033588663
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 03/08/2024
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 63 KG