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

Model Number	M0061903230
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of coil detachment of device, inside the patient.Imdrf f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported that during the procedure, issues with the lack of curl memory on the distal end of the tria soft stents.It doesn't easily curl in the bladder and in this case the coil broke off.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of coil detachment of device, inside the patient.Imdrf f23 captures the reportable investigation results of unexpected medical intervention.Block h11: the tria ureteral stent was not returned for analysis, however, the customer provided media of the device.It showed two tria ureteral stents, based on the media provided, the stent that is on the left side would be use as the reference for complaint record (b)(4) while the stent that is on the right side would be use as the reference for complaint record (b)(4).For the stent that is on the left side, it was possible to observe that the bladder coil was fully detached which confirms the reported event of coil detachment of device or device component.However, the reported event of coil memory could not be appreciated in the stent with the evidence provided since the bladder coil was already detached from the stent.The reported event of coil memory could not be appreciated in the stent with the evidence provided since the bladder coil was already detached from the stent.For that reason, the most probable cause of the reported issue cannot be established due to lack of evidence.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.
Event or Problem Description
It was reported that during the procedure, issues with the lack of curl memory on the distal end of the tria soft stents.It doesn't easily curl in the bladder and in this case the coil broke off.The procedure was completed with another of the 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: 22727187
• Report Number: 2124215-2025-54603
• Device Sequence Number: 18427761
• Product Code: FAD
• UDI-Device Identifier: 08714729959908
• UDI-Public: (01)08714729959908(17)280204(10)35777825
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061903230
• Device Catalogue Number: M0061903230
• Device Lot Number: 0035777825
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 02/04/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown