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

Model Number	M0061903320
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code a0406 captures the reportable event of stent kinked inside the patient.
Event or Problem Description
It was reported that a tria ureteral stent was used in a ureteroscopy procedure in the kidney, ureter and bladder.During insertion, it was noticed that the stent kinked.The procedure was completed with another of the dame device and there were no patient complications reported.
Event or Problem Description
It was reported that a tria ureteral stent was used in a ureteroscopy procedure in the kidney, ureter and bladder.During insertion, it was noticed that the stent kinked.The procedure was completed with another of the dame device and there were no patient complications reported.Additional information received on october 03, 2025, clarified that the event occurred outside the patient and the coil was also detached.
Additional Manufacturer Narrative
Block h6: device code a0406 captures the reportable event of stent kinked inside the patient.Blocks b5, e1, e3, and h6, have been updated based on the additional information received on october 03, 2025.Additional information was received from the complainant on october 03, 2025, clarified that the reported issue was the coil was also detached, however, the event occurred outside the patient.Although this can result in a clinically insignificant delay of the procedure, this event is unlikely to cause or contribute to a death or serious injury if the malfunction were to recur.Based on the review of the information, this event no longer meets reporting criteria.

• 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: 23206375
• Report Number: 2124215-2025-68593
• Device Sequence Number: 9729910
• Product Code: FAD
• UDI-Device Identifier: 08714729959939
• UDI-Public: (01)08714729959939(17)280130(10)35745977
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 10/29/2025

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: M0061903320
• Device Catalogue Number: M0061903320
• Device Lot Number: 0035745977
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 10/29/2025
• Date Device Manufactured: 01/30/2025
• 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