MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRIA? SOFT; STENT, URETERAL

Model Number	M0061903220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that a tria ureteral stent was used in cystoscopy with stent procedure.During the procedure, it was noticed that the stent broke apart.The procedure was completed with another of the 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: the device was not returned for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without a proper evaluation of the device or objective evidence, it remains unknown the most probable causes that could have contributed to the event.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 shaft break was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, this complaint is assigned an investigation conclusion code of cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
Event or Problem Description
It was reported that a tria ureteral stent was used in cystoscopy with stent procedure.During the procedure, it was noticed that the stent broke apart.The procedure was completed with another of the same device and there were no patient complications reported.

• Brand Name: TRIA? SOFT
• 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: 24671126
• Report Number: 2124215-2026-15945
• Device Sequence Number: 5042895
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: (01)08714729959892(17)281109(10)37921720
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: M0061903220
• Device Catalogue Number: M0061903220
• Device Lot Number: 0037921720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 11/10/2025
• 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