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

Model Number	M0061902320
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the end of the product crumpled and does not go in.The procedure was completed with another of the same device and there were no known patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of stent buckled material, inside the patient.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during the procedure, the end of the product crumpled and does not go in.The procedure was completed with another of the same device and there were no known patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of stent buckled material, inside the patient.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h11: the returned tria ureteral stent was analyzed, and during the inspection, it was found that the stent bladder coil buckled, which confirm the reported event.The analysis performed to the returned device; it is possible to conclude that this problem could be caused by operational factors.Based on the analysis results stent buckled, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of stent buckled material, inside the patient.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h11: correction to product analysis.The returned tria ureteral stent with positioner and suture were analyzed, and during the inspection, it was found that the stent bladder coil buckled, which confirm the reported event.The analysis performed to the returned device; it is possible to conclude that this problem could be caused by operational factors.Based on the analysis results stent buckled, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that during the procedure, the end of the product crumpled and does not go in.The procedure was completed with another of the same device and there were no known patient complications reported.

• 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; 546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22982321
• Report Number: 2124215-2025-62444
• Device Sequence Number: 9370521
• Product Code: FAD
• UDI-Device Identifier: 08714729937906
• UDI-Public: (01)08714729937906
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2025

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: M0061902320
• Device Catalogue Number: M0061902320
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 11/06/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/10/2025; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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