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

Model Number	M0061552310
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn.
Event or Problem Description
It was reported that, during a ureteroscopy procedure using a polaris loop ureteral stent, the loop was broken when the physician pushed the device into the bladder.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn.Correction to block e1: zip code.Correction to block e1: initial reporter city.Block h11: the complaint device was not returned therefore, product analysis could not be performed, for this reason and due to the lack of evidence is unable to confirm the reported event.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 and analysis results, the most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without proper evaluation of the device or objective evidence, it remains unknown the most probable causes that could have contributed to the event.Therefore, an investigation conclusion code of unable to exclude device problem was assigned to this investigation.
Event or Problem Description
It was reported that, during a ureteroscopy procedure using a polaris loop ureteral stent, the loop was broken when the physician pushed the device into the bladder.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: POLARIS? LOOP
• 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: 23983542
• Report Number: 2124215-2026-00793
• Device Sequence Number: 10703924
• Product Code: FAD
• UDI-Device Identifier: 08714729421078
• UDI-Public: (01)08714729421078(17)280312(10)36055572
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K030503
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: M0061552310
• Device Catalogue Number: M0061552310
• Device Lot Number: 0036055572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 03/13/2025
• 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