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

Model Number	M0061903240
Medical Device Problem Codes	Unsealed Device Packaging (1444); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tria ureteral stent was to be used in a procedure.During unpacking, it was found that the inner pouch had a cut from top to bottom.The procedure was completed with another of the same device and there were no patient complications reported.Note: this report pertains to one of two tria ureteral stents used in the same procedure.Report # 2124215-2025-38648 and report# 2124215-2025-38649.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code a020503 captures the reportable event of packaging seal compromised.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code a020503 captures the reportable event of packaging seal compromised.Block h6 device code has been corrected.The device was not returned for analysis; therefore, no physical or visual analysis of the product could be performed.However, based on the media provided in the attachment section, the photo showed a tria ureteral stent in its inner bag and as per bag it states: "slit top web only", which means that this opening in the inner bag is normal, indicating there is no sealing problem with the device.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that a tria ureteral stent was to be used in a procedure.During unpacking, it was found that the inner pouch had a cut from top to bottom.The procedure was completed with another of the same device and there were no patient complications reported.Note: this report pertains to one of two tria ureteral stents used in the same procedure.Report # 2124215-2025-38648 and report# 2124215-2025-38649.

• 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: 22215937
• Report Number: 2124215-2025-38649
• Device Sequence Number: 18182059
• Product Code: FAD
• UDI-Device Identifier: 08714729959915
• UDI-Public: (01)08714729959915(17)271210(10)35455070
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/17/2025

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: M0061903240
• Device Catalogue Number: M0061903240
• Device Lot Number: 0035455070
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 12/10/2024
• 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