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

Model Number	M0061921550
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of stent buckled material, inside the patient.
Event or Problem Description
It was reported that during insertion, when the stent was pushed up using as positioner, the tail was bucked and failed to insert it.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
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 reported event of stent buckled material is confirmed.During the visual, magnification inspection, and media inspection it was found that the stent shaft buckled.Regarding to the analysis performed to the returned device, it is possible to conclude that this issue could be caused by operational factors.If the positioner is advanced with excess force over the guidewire the stent can get buckled or accordioned resulting in a difficulty unable to advance the stent to the target site.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 insertion, when the stent was pushed up using as positioner, the tail was bucked and failed to insert it.The procedure was completed with another of the same device.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: 21549852
• Report Number: 2124215-2025-12791
• Device Sequence Number: 4402187
• Product Code: FAD
• UDI-Device Identifier: 08714729124726
• UDI-Public: (01)08714729124726(17)270102(10)33129838
• 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): 04/16/2025

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: M0061921550
• Device Catalogue Number: M0061921550
• Device Lot Number: 0033129838
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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: Male