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

Model Number	M0061921530
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a040601 captures the reportable investigation results of stent buckled material, inside the patient.
Event or Problem Description
It was reported that during a ureteroscopy procedure while inside the patient, the polaris ultra stent was pushed up using the positioner, the tail was buckled.The procedure was completed using another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block b1: updated to product problem.Block h6: imdrf device code a040601 captures the reportable investigation results of stent buckled material, inside the patient.Block h11: the polaris ultra ureteral stent was returned for analysis.The suture and the positioner did not return.The reported event of stent buckled material will not be confirmed and will be documented as no problem detected.During the visual, magnification inspection, wire insertion, and dimension test, it was found that the suture hole torn until the tip.No buckles were observed on the stent.A sensor wire of 0.038 previously immersed in saline solution was inserted into the stent to evaluate if some resistance is felt inside the device, however, no resistance was felt during the analysis performed and the guidewire was able to fully pass through the stent.Additionally, a dimensional inspection confirmed that the tip inner diameter was within specification.It was not possible also to identify any evidence of the alleged issues on the device since the stent was not buckled and also the guidewire was able to fully pass through the stent.Additionally, the suture did not return indicating that it was removed, and the device was used.This failure could have been caused due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied over the device during the procedure.Consequently, affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions, since the main problem found was traced to the user not following the manufacturer's instructions.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported that during procedure, when the stent was pushed up using the positioner, the tail was buckled.The procedure was completed using another of the same device and there were no patient complications reported.

• 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: 21358503
• Report Number: 2124215-2025-06213
• Device Sequence Number: 8481646
• Product Code: FAD
• UDI-Device Identifier: 08714729720942
• UDI-Public: (01)08714729720942(17)270529(10)34130466
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/04/2025

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: M0061921530
• Device Catalogue Number: M0061921530
• Device Lot Number: 0034130466
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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 Sex: Female