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

Model Number	M0061902120
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that prior to a retrograde intrarenal surgery procedure, a tria ureteral stent was broken during guidewire insertion while preparing for the procedure.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf code a0401 captures the reportable event of stent shaft break.Block h11: investigation results the returned tria ureteral stent was analyzed.During inspection, it was found that the stent bladder coil was detached and the suture hole was torn, which did confirm the reported event.Based on the available information and the analysis performed on the returned device, the investigation determined that the reported problem could be due to operational factors.The retrieval line may be removed prior to placement at the physician's discretion.If the retrieval line becomes entangled with the bladder coil and is removed using excessive force, the stent may detach, separate, or tear during preparation, which can affect device performance.No manufacturing or material abnormalities were identified during the evaluation.Also, for the reported event of stent shaft break, it could be confirmed based on the damage found on the device.The device history record review was completed, and it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of "stent shaft break, suture hole torn and coil detached/separated" were defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Based on a thorough review of the reported complaint, a conclusion code of adverse event related to procedure was assigned to this investigation.Correction to field d5: operator of device: operator of device.
Event or Problem Description
It was reported that prior to a retrograde intrarenal surgery procedure, a tria ureteral stent was broken during guidewire insertion while preparing for the procedure.The procedure was completed with another of the same device.No patient complications were noted.

• 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: 24243457
• Report Number: 2124215-2026-05978
• Device Sequence Number: 18634634
• Product Code: FAD
• UDI-Device Identifier: 08714729937784
• UDI-Public: (01)08714729937784(17)280622(10)36816111
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: M0061902120
• Device Catalogue Number: M0061902120
• Device Lot Number: 0036816111
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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: Male