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

Model Number	M0061921330
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of stent torn material inside the patient.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a ureteroscopy with laser lithotripsy procedure in the bladder.During the procedure, when attempting to deploy the stent, it got stuck on the guidewire, causing the stent to disintegrate and rip.The procedure was completed with another of the 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: 23423755
• Report Number: 2124215-2025-76716
• Device Sequence Number: 15859660
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: (01)08714729124443(17)270911(10)34827274
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 10/30/2025

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: 0034827274
• 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: 10/03/2025
• Initial Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 09/11/2024
• 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 Sex: Unknown