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

Model Number	M0061903230
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tria ureteral stent was used in a ureteroscopy procedure.During the procedure, when the physician attempted to place the stent and removed the guidewire, the stent did not fully coil in the kidney.The procedure was completed with another same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a04 captures the reportable event of coil memory.
Additional Manufacturer Narrative
Device code a04 captures the reportable event of coil memory.Upon receipt at our quality assurance laboratory, this tria ureteral stent underwent a thorough analysis.Visual analysis identified that the stent renal coil was kinked.The suture was also returned for analysis.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Based on the information available and analysis results, the reported allegation of coil memory was confirmed.Regarding the analysis, it is possible to conclude that the issue could be caused by operational factors, possibly by manipulation during the procedure have caused kinks.A conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that a tria ureteral stent was used in a ureteroscopy procedure.During the procedure, when the physician attempted to place the stent and removed the guidewire, the stent did not fully coil in the kidney.The procedure was completed with another same device and there were no patient complications reported.

• 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: 21884374
• Report Number: 2124215-2025-24957
• Device Sequence Number: 16995554
• Product Code: FAD
• UDI-Device Identifier: 08714729959908
• UDI-Public: (01)08714729959908(17)271205(10)35420705
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/12/2025

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: 0035420705
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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