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

Model Number	M0061902220
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during preparation, after removing the packaging, the stent was broken when the thread was removed.The procedure was completed with another of the same device and the patient condition was reported to be stable.
Additional Manufacturer Narrative
Block h6: conclusion code 4316 is being used to capture that the event is no longer reportable.The tria ureteral stent coil was clarified to be detached, occurred outside the patient, and determined that this event no longer meets reporting criteria.This event is now considered non reportable.Block b5 and h6 has been updated based on additional information was received on march 09, 2025.Block h11: block h6 device code has been corrected.
Event or Problem Description
It was reported that during preparation, after removing the packaging, the stent was broken when the thread was removed.The procedure was completed with another of the same device and the patient condition was reported to be stable.

• 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: 21665693
• Report Number: 2124215-2025-17167
• Device Sequence Number: 18057874
• Product Code: FAD
• UDI-Device Identifier: 08714729937845
• UDI-Public: (01)08714729937845(17)270903(10)34767493
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 0034767493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 03/09/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/03/2025
• Date Device Manufactured: 09/03/2024
• 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: 54 YR
• Patient Sex: Male