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

Model Number	M0061552230
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a180104 captures the reportable event of device foreign material present in device.
Event or Problem Description
It was reported that a polaris loop ureteral stent was to be used in a ureteroscopic stent placement procedure.During unpacking, a flocculent was found on the stent.The procedure was completed with another same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block e1: initial reporter's facility name (b)(6).Block h6: device code a180104 captures the reportable event of device foreign material present in device.Block h11: investigation analysis the returned polaris loop ureteral stent was analyzed, and during the inspection, there was no foreign matter found present on the device.The reported event was not confirmed.The positioner and an open pouch were also returned.Based on the most relevant information, the analysis performed to the returned device, it was not possible to identify any evidence of either the alleged issue or any defect on the device.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.A risk review was completed and confirmed that the event of device foreign material present in device was defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Based on the results of the device evaluation, an investigation conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that a polaris loop ureteral stent was to be used in a ureteroscopic stent placement procedure.During unpacking, a flocculent was found on the stent.The procedure was completed with another same device and there were no patient complications 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: 23981064
• Report Number: 2124215-2026-00739
• Device Sequence Number: 18793838
• Product Code: FAD
• UDI-Device Identifier: 08714729421030
• UDI-Public: (01)08714729421030(17)270309(10)33594790
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: M0061552230
• Device Catalogue Number: M0061552230
• Device Lot Number: 0033594790
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2024
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 75 KG