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

Model Number	M0061921230
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of coil detachment of device, inside the patient.Imdrf f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported that during the procedure, when it was put inside the patient, the tip was fractured and it could not be used.The procedure was completed with another of the same device and the patient condition following procedure was stable.
Additional Manufacturer Narrative
Outcomes attribute to adverse event, has been corrected.Imdrf device code a0501 captures the reportable investigation results of coil detachment of device, inside the patient.Imdrf f23 captures the reportable investigation results of unexpected medical intervention.The polaris ultra ureteral stent was returned with the box, and without the detached renal coil for analysis.During the visual, media, and device under magnification inspection, it was found that the renal coil was detached, which confirms the reported event.It is possible to conclude that this issue could be caused by operational factors.Probably some manipulation during the procedure could have caused the detachment of the renal coil affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure, since the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that during the procedure, when it was put inside the patient, the tip was fractured and it could not be used.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: 22895891
• Report Number: 2124215-2025-59352
• Device Sequence Number: 18366852
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: (01)08714729124320(17)271011(10)35043149
• 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): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061921230
• Device Catalogue Number: M0061921230
• Device Lot Number: 0035043149
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 90 KG