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

Model Number	M006192123090
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used during a stent placement procedure in the kidney.During the procedure, it was noticed that the guidewire was unable to cross over the stent.The procedure was completed with another same device and there were no patient complications reported.This event has been deemed a reportable event based on the investigation finding of stent buckled material inside the patient.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a040601 captures the reportable investigation result of stent buckled material, inside the patient.Block h11: upon receipt at our quality assurance laboratory, this polaris ultra ureteral stent underwent a thorough analysis.Visual inspection of the device revealed that the stent bladder coil was buckled.The suture was not returned for analysis.A functional test revealed that, it failed when a mandrel of 0.036 in was inserted into the stent to evaluate if some resistance was felt inside the device, however, a resistance was felt during the analysis performed and the mandrel was not able to fully pass through the stent due to the buckled 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.Based on the information available and analysis results, 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 could get buckled/accordioned resulting in a difficulty/unable to advance the stent to the target site.A conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 22921097
• Report Number: 2124215-2025-59616
• Device Sequence Number: 9107200
• Product Code: FAD
• UDI-Device Identifier: 08714729124337
• UDI-Public: (01)08714729124337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/04/2026

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: M006192123090
• Device Catalogue Number: M006192123090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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