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

Model Number	M0061921340
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: based on the ar component code 5595 and ar device code 1048, stent shaft break, this complaint has been determined to be an mdr reportable.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was to be used in a ureteroscopy (urs) procedure.During unpacking, it was found that the stent was broken.The procedure was completed with another same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.Block h11: investigation result upon receipt at our quality assurance laboratory, this polaris ultra stent underwent a thorough analysis.Visual analysis identified that the stent shaft was detached, torn and kinked.The suture was not returned.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 the issue could be caused by operational factors.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 was removed using excess force, the stent can get torn during the procedure affecting the performance of the device.A conclusion code of adverse event related to procedure was assigned to this investigation.Block h8 usage of device has been corrected.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was to be used in a ureteroscopy (urs) procedure.During unpacking, it was found that the stent broke.The procedure was completed with another 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: 21981432
• Report Number: 2124215-2025-28829
• Device Sequence Number: 8480063
• Product Code: FAD
• UDI-Device Identifier: 08714729124467
• UDI-Public: (01)08714729124467(17)270715(10)34434776
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: M0061921340
• Device Catalogue Number: M0061921340
• Device Lot Number: 0034434776
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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