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

Model Number	M0061902230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that a tria ureteral stent was to be used in a procedure.During preparation, when the suture was pulled, the stent got separated.The procedure was completed with another of the same device and there were no patient complications reported.
Event or Problem Description
It was reported that a tria ureteral stent was to be used in a procedure.During preparation, when the suture was pulled, the stent got separated.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a0401 captures the reportable event of stent shaft break.Correction to block d4 lot number and (root parent) unique identifier (udi) #.Upon receipt at our quality assurance laboratory, this tria firm ureteral stent underwent a thorough analysis.Visual inspection of the device revealed that the bladder coil was fully detached.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 reported allegation of stent shaft break was not confirmed.Furthermore, the suture returned assembled in the suture hole, but it was cut indicating it was intended to be removed.This failure could have been caused due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied over the device during the setting up.Additionally, the suture string/retrieval line is intended to be removed before procedure and as per event, it occurred in the preparation meaning that the suture must have been cut and gently removed, however, the evidence shows the contrary with the found issue.A conclusion code of failure to follow instructions was assigned to this investigation.

• 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: 22216236
• Report Number: 2124215-2025-38651
• Device Sequence Number: 12799204
• Product Code: FAD
• UDI-Device Identifier: 08714729937852
• UDI-Public: (01)08714729937852(17)271114(10)35284296
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: M0061902230
• Device Catalogue Number: M0061902230
• Device Lot Number: 0035284296
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 11/14/2024
• 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