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

Model Number	M0061903220
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	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tria ureteral stent was to be used in a retrograde intrarenal surgery.During unpacking, it was found 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 of stent shaft break.
Event or Problem Description
It was reported that a tria ureteral stent was to be used in a retrograde intrarenal surgery.During unpacking, it was found that the stent was broken.The procedure was completed with another of the same device and there were no patient complications reported.Additional information received on october 28, 2025, stating that the coil part of the stent was broken.
Additional Manufacturer Narrative
Blocks b5 and h6 have been updated based on the additional information received on october 28, 2025.Additional information was received from the complainant, clarified that the reported issue was the coil of the stent was detached/broken.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: 23386503
• Report Number: 2124215-2025-74902
• Device Sequence Number: 9046426
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: (01)08714729959892(17)280423(10)36366445
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: M0061903220
• Device Catalogue Number: M0061903220
• Device Lot Number: 0036366445
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/21/2025
• Date Device Manufactured: 04/24/2025
• 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: Female