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

Model Number	M0061903210
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of coil detachment of device, inside the patient.Imdrf f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported that during the procedure, while placing the stent by the physician a piece broke off.The physician was able to retrieve the broken piece.The procedure was completed with another of the same device and there 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: 22731903
• Report Number: 2124215-2025-54605
• Device Sequence Number: 9051143
• Product Code: FAD
• UDI-Device Identifier: 08714729959885
• UDI-Public: (01)08714729959885(17)280203(10)35767209
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061903210
• Device Catalogue Number: M0061903210
• Device Lot Number: 0035767209
• 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: 07/17/2025
• Initial Report FDA Received Date: 08/06/2025
• Date Device Manufactured: 02/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown