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

Model Number	M0061902130
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during preparation, the ureteral stent was found fractured.The procedure was completed with another of the same device.The patient condition following procedure was stable.
Event or Problem Description
It was reported that during preparation, the ureteral stent was found fractured.The procedure was completed with another of the same device.The patient condition following procedure was stable.Additional information was received on january 15, 2025, that the coil was detached from the stent.
Additional Manufacturer Narrative
Correction: additional information was received from the complainant on january 15, 2025, stated that the coil was detached from the stent.Due to the additional information received, the event is no longer considered reportable.Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Blocks b5 and h6 have been updated based on additional information received january 15, 2025.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20847667
• Report Number: 2124215-2024-76022
• Device Sequence Number: 3928607
• Product Code: FAD
• UDI-Device Identifier: 08714729937791
• UDI-Public: 08714729937791
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 02/05/2025

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 Expiration Date: 09/20/2025
• Device Model Number: M0061902130
• Device Catalogue Number: M0061902130
• Device Lot Number: 0030191598
• 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: 11/09/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/05/2025
• Date Device Manufactured: 09/21/2022
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 70 KG