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

Model Number	M0061903220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event stent shaft break.
Event or Problem Description
It was reported that a tria ureteral stent was used in a procedure and the stent was cut off.There was no information on what completed the procedure and there were no known patient complications reported.
Event or Problem Description
It was reported that a tria ureteral stent was used in a procedure and the stent was cut off.There was no information on what completed the procedure and there were no known patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event stent shaft break.Block h11: investigation analysis upon receipt at our quality assurance laboratory, this tria ureteral stent underwent a thorough analysis.Visual analysis identified that the stent bladder coil was detached from the shaft.The positioner, the pouch, and the suture were also returned for analysis.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.Based on the information available and analysis results, the retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the stent coil and is removed using excess force, the stent could get detached/separated during the preparation, affecting the performance of the device.A conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 21904725
• Report Number: 2124215-2025-25645
• Device Sequence Number: 4085377
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: (01)08714729959892(17)271104(10)35209826
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: M0061903220
• Device Catalogue Number: M0061903220
• Device Lot Number: 0035209826
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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