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

Model Number	M0061903310
Medical Device Problem Codes	Nonstandard Device (1420); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn.
Event or Problem Description
It was reported that during a procedure, a tria ureteral stent was used, and noticed that the catheter cuts itself off.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn.Block h11: the returned tria soft ureteral stent with suture and positioner was analyzed.During the inspection was found stent bladder coil detached, which did not confirm the reported event of stent torn.Based on the information available and analysis results, it is possible to conclude that this problem could be caused by operational factors.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.A risk review was completed and confirmed that the event of "stent torn material and stent coil detached/separated" were defined in the risk documentation.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, an investigation conclusion code ofadverse event related to procedure was assigned to this investigation.Additional information for field a2: age, a3a sex, a3b gender, a4 weight, a4 measurement of weight, e1: initial reporter title, initial reporter first and last name; and for block e3: occupation.
Event or Problem Description
It was reported that during a procedure, a tria ureteral stent was used, and noticed that the catheter cuts itself off.No patient complications were 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: 25009941
• Report Number: 2124215-2026-22760
• Device Sequence Number: 9965242
• Product Code: FAD
• UDI-Device Identifier: 08714729959922
• UDI-Public: (01)08714729959922(17)280817(10)37234573
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: M0061903310
• Device Catalogue Number: M0061903310
• Device Lot Number: 0037234573
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 70 KG