MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Polaris Ultra; stent, ureteral

Model Number	M0061921320
Medical Device Problem Codes	Nonstandard Device (1420); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a polaris ultra was used during ureteroscopic lithotripsy.During procedure, it was found that there is a crack at the distal end of dj stent.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of material split, cut or torn.Block h11: the polaris ultra was returned for analysis.During the inspection was found the shaft detached.The reported stent torn material was not confirmed since the device was found detached instead.Regarding to the analysis performed to the returned device, it is possible to conclude that this issue could be caused by operational factors.The retrieval line may be removed before placement at the physician discretion.If the retrieval line gets entangled in the shaft and is removed using excess force, the stent can get detached or separated during the preparation affecting the performance of the device.A review of the device history record (dhr) was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the events of stent torn material and stent detached or separated were defined in the risk documentation and is documented accordingly.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.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.

• 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: 50817244
• Report Number: 2124215-2026-49891
• Device Sequence Number: 10713013
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: (01)08714729124429(17)280826(10)37311865
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: M0061921320
• Device Catalogue Number: M0061921320
• Device Lot Number: 0037311865
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• 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