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

Model Number	M0061921320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: facility name: (b)(6) hospital.Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during unpacking, it was found that the stent was fractured.The procedure was completed with another of the same device and the patient condition following procedure was stable.
Additional Manufacturer Narrative
Block e1: facility name: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: the returned polaris ureteral stent was analyzed, and during the inspection, it was found the stent detached in two sections, which confirm the reported event.Based on the investigation, performed to the returned device, it is possible to conclude that this problem could be caused by operational factors.Based on the analysis results regarding the observed detached stent, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that during unpacking, it was found that the stent was fractured.The procedure was completed with another of the same device and the patient condition following procedure was stable.

• 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: 23295989
• Report Number: 2124215-2025-72661
• Device Sequence Number: 4863989
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: (01)08714729124429(17)271220(10)35519909
• 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): 11/21/2025

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: M0061921320
• Device Catalogue Number: M0061921320
• Device Lot Number: 0035519909
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 78 KG