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

Model Number	M0061902320
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the preparation, after unpacking, before use, when it was pulled, it was fractured.The procedure was completed with another of the same device and the patient condition following procedure was stable.
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during the preparation, after unpacking, before use, when it was pulled, it was fractured.The procedure was completed with another of the same device and the patient condition following procedure was stable.
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of stent shaft break.The returned tria ureteral stent was analyzed; however, the suture did not return.Upon inspection, it was found that the stent shaft had become detached and kinked, and both coils of the stent were also found to be detached.Furthermore, it was noted that some drainage holes were torn, which confirms the reported events of "coil detachment of device or device component" and "stent shaft break." the stent had kinked on the returned device; it is possible to conclude that this issue could be caused by operational factors.It is likely that some manipulation during the procedure could have resulted in the kinks.Based on the results of the analysis observed, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 22682682
• Report Number: 2124215-2025-50329
• Device Sequence Number: 13123617
• Product Code: FAD
• UDI-Device Identifier: 08714729937906
• UDI-Public: (01)08714729937906(17)261221(10)33109394
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/27/2025

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: M0061902320
• Device Catalogue Number: M0061902320
• Device Lot Number: 0033109394
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2023
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 63 KG