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

Model Number	M0061902130
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the guidewire "crossed through" upon placing this stent.However, the stent did not advance up into the ureter, and it was determined that it could not be placed.Another of the same 6fr product was used to complete the procedure and placement was successful.There were no patient injuries reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable investigation results of stent buckled material, inside the patient.Block h11: the tria ureteral stent was returned with the pouch for analysis, however, the suture did not return.The reported event of stent buckled material will be confirmed.During the visual and device under magnification inspection, it was found with the stent bladder coil and renal coil buckled.It is possible to conclude that this issue could be caused by operational factors.If the positioner is advanced with excess force over the guidewire the stent can get buckled or accordioned resulting in a difficulty to advance, the stent to the target site.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.

• 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: 23065927
• Report Number: 2124215-2025-64879
• Device Sequence Number: 10044839
• Product Code: FAD
• UDI-Device Identifier: 08714729937791
• UDI-Public: (01)08714729937791(17)271028(10)35164396
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/08/2026

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: M0061902130
• Device Catalogue Number: M0061902130
• Device Lot Number: 0035164396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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 Sex: Unknown