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

Model Number	M0061921330
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name (b)(6).Block h6: device code a0401 captures the reportable event of stent shaft break.This event was reported by the distributor.The health care facility is: (b)(6) hospital.China.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a procedure.During the procedure, it was noticed that the stent was fractured.The procedure was completed with another same device and there were no patient complications reported.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a procedure.During the procedure, it was noticed that the stent was fractured.The procedure was completed with another same device and there were no patient complications reported.Additional information with a photo provided on september 18, 2025, showed that the stent was torn.
Additional Manufacturer Narrative
Block e1: initial reporter facility name (b)(6).This event was reported by the distributor.The health care facility is: (b)(6) china.Blocks b5 and h6, have been updated based on the additional information received.Additional information was received from the complainant on september 18, 2025, including a photo that clarified the reported issue was a torn stent.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.Based on the review of the information, this event no longer meets reporting criteria.

• 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: 23089711
• Report Number: 2124215-2025-64743
• Device Sequence Number: 13387426
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: (01)08714729124443(17)270510(10)34009905
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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: 0034009905
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 05/10/2024
• 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