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

Model Number	M0061902120
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the preparation prior to procedure, the physician opened a tria stent and he observed the device was kinked.The procedure was rescheduled and there were no patient complications reported.
Additional Manufacturer Narrative
Imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported that during the preparation prior to procedure, the physician opened a tria stent and he observed the device was kinked.The procedure was rescheduled and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable investigation results of aborted/cancelled procedure.Block h11: the tria ureteral stent was returned with opened box and positioner for analysis.During the inspection, it was found the stent bladder coil kinked into two sections., which confirms the reported event of stent kinked.Since the investigation findings did not lead to a clear conclusion about the cause of the failures, all compiled information on this investigation determines that this complaint is assigned an investigation conclusion code of "cause not established".
Event or Problem Description
It was reported that during the preparation prior to procedure, the physician opened a tria stent and he observed the device was kinked.The procedure was rescheduled and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable investigation results of aborted/cancelled procedure.Block h11: the tria ureteral stent was not returned for analysis.However, the customer provided a photo of the device.It showed part of a tria ureteral stent that had the bladder coil kinked in two sections which confirms the reported event of stent kinked.The most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without a proper evaluation of the device, it remains unknown the most probable causes that could have contributed to the event.A conclusion code of cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.

• 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: 22401118
• Report Number: 2124215-2025-44362
• Device Sequence Number: 8294237
• Product Code: FAD
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/29/2026

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: 0035256090
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 09/29/2025; 07/03/2026
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/07/2025; 10/24/2025; 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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