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

Model Number	M0061903230
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a percutaneous nephrolithotomy (pcnl) procedure, the tria ureteral stent was placed and the sutures were removed from stent per usual.After stent insertion, fluoroscopy was used and it was noted that the coiling was not coiling properly.The stent was removed, and a small tear was noted.Stent discarded per surgeon, new stent placed with no issue.The were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn material, inside the patient.
Event or Problem Description
It was reported that during a percutaneous nephrolithotomy (pcnl) procedure, the tria ureteral stent was placed and the sutures were removed from stent per usual.After stent insertion, fluoroscopy was used and it was noted that the coiling was not coiling properly.The stent was removed, and a small tear was noted.Stent discarded per surgeon, new stent placed with no issue.The were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation results of stent torn material, inside the patient.Block h11: the tria ureteral stent was not returned for analysis, however, the customer provided media of the device.It showed that the coil was torn and that was fully detached from the rest of the stent which confirms the reported event of stent torn material and shows evidence of stent coil detached or separated.It is possible to conclude that these issues could be caused by operational factors.Probably some manipulation during the procedure could have caused the tear and then the detachment of the coil.For that reason, the reported event of stent torn material and the issue found of stent coil detached or separated will be documented as adverse event related to procedure.Therefore, this complaint is assigned an investigation conclusion code of cause not established since the investigation findings do not lead to a clear conclusion about the cause of some of the reported adverse events.

• 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: 22782607
• Report Number: 2124215-2025-54611
• Device Sequence Number: 10045654
• Product Code: FAD
• UDI-Device Identifier: 08714729959908
• UDI-Public: (01)08714729959908(17)271218(10)35516662
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: M0061903230
• Device Catalogue Number: M0061903230
• Device Lot Number: 0035516662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 12/18/2024
• 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