MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Tria? Firm; stent, ureteral

Model Number	M0061902110
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tria ureteral stent was used in a retrograde intrarenal surgery procedure in the left kidney.During the procedure, when the stent was inserted, it was noticed that the stent was torn and the coil was detached.The procedure was completed with another of the same device and there were no patient complications reported.
Event or Problem Description
It was reported that a tria ureteral stent was used in a retrograde intrarenal surgery procedure in the left kidney.During the procedure, when the stent was inserted, it was noticed that the stent was torn and the coil was detached.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of stent torn material inside the patient.Device code a0501 captures the reportable event of coil detached inside the patient.
Additional Manufacturer Narrative
Block h6: device code a0414 captures the reportable event of stent torn material inside the patient.Device code a0501 captures the reportable event of coil detached inside the patient.Block h11: investigation analysis upon receipt at our quality assurance laboratory, this tria ureteral stent underwent a thorough analysis.Visual and magnification analysis identified that the bladder coil was detached and the suture hole was torn until the tip.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.A risk review was completed and confirmed that the event of coil detachment of device or device component and stent torn material 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 the information available and analysis results, it is possible to conclude that this issue could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the bladder coil including the tip and is removed using excess force, the stent can get detached/separated and torn during the preparation affecting the performance of the device.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.

• 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: 50211005
• Report Number: 2124215-2026-42950
• Device Sequence Number: 17670017
• Product Code: FAD
• UDI-Device Identifier: 08714729937777
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K190603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/16/2026

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: M0061902110
• Device Catalogue Number: M0061902110
• Device Lot Number: 0038412499
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2026
• 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