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

Model Number	M006192132050
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material.Device code a0414 captures the reportable event of stent torn material.Device code a04 captures the reportable event of coil memory.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a percutaneous nephrolithotomy procedure in the kidney.During the procedure, when the physician attempted to remove the guidewire, it got torn and the stent's distal part did not completely coil.Picture provided by the customer showed that the stent was buckled.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material.Device code a0414 captures the reportable event of stent torn material.Device code a04 captures the reportable event of coil memory.Block h11: investigation analysis the returned polaris ultra ureteral stent was analyzed, and during the inspection, it was found that the bladder coil was buckled accordion and torn, additionally, a part of the shaft was also buckled.The reported event was confirmed.Based on the most relevant information, 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/accordioned.Additionally, the retrieval line may be removed before placement at the physician's discretion, and if the retrieval line gets entangled in the bladder coil and is removed using excess force, the stent can get torn.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.A risk review was completed and confirmed that the event of stent torn material, coil memory and stent buckled material were defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Based on the results of the device evaluation, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a percutaneous nephrolithotomy procedure in the kidney.During the procedure, when the physician attempted to remove the guidewire, it got torn and the stent's distal part did not completely coil.Picture provided by the customer showed that the stent was buckled.The procedure was completed with 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: 22583440
• Report Number: 2124215-2025-48975
• Device Sequence Number: 18476783
• Product Code: FAD
• UDI-Device Identifier: 08714729784319
• UDI-Public: (01)08714729784319(17)270723(10)35191688
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: M006192132050
• Device Catalogue Number: M006192132050
• Device Lot Number: 0035191688
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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: Unknown