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

Model Number	M0061902220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tria ureteral stent was used in a procedure.During the procedure, it was noticed that the stent was broken.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 stent shaft break.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event stent shaft break.Block h11: investigation result upon receipt at our quality assurance laboratory, this tria firm ureteral stent underwent a thorough analysis.Visual analysis identified that the stent bladder coil was completely detached from the shaft.The suture and the detached part were returned for analysis, which confirmed the reported event.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Based on the information available and analysis results, it is possible to conclude that this issue could be caused by operational factors, the retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the bladder coil and is removed using excess force, the stent can get detached/separated during the procedure, affecting the performance of the device.
Event or Problem Description
It was reported that a tria ureteral stent was used in a procedure.During the procedure, it was noticed that the stent was broken.The procedure was completed with another of the same device and there were no patient complications reported.

• Brand Name: TRIA? FIRM
• 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: 21879054
• Report Number: 2124215-2025-24727
• Device Sequence Number: 8769272
• Product Code: FAD
• UDI-Device Identifier: 08714729937845
• UDI-Public: (01)08714729937845(17)271009(10)35032228
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K190603
• 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): 06/13/2025

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: M0061902220
• Device Catalogue Number: M0061902220
• Device Lot Number: 0035032228
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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 Age: 60 YR
• Patient Sex: Male