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

Model Number	M0061902130
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
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 unpacking, the stent was found fractured into two parts.The procedure was completed with another of the same device.The patient condition following procedure was stable.
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of stent shaft break.The tria ureteral stent was returned for analysis.During the microscope and visual inspection, the stent was found with the stent detached near the renal coil and the suture hole is torn until the tip.Additionally, the positioner and the suture did not return the reported event of stent shaft break will be confirmed.Also, the suture hole is torn until the tip probably caused by the suture.These failures 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.Consequently, affect the performance of the device.Additionally, if the suture string or retrieval line is intended to be removed before procedure the instructions for use states that, the retrieval line may be cut prior to stent placement.Remove the retrieval line by holding the knot, cutting one strand, and while holding the knot, gently pull out the retrieval line.According to the reported event the issue occurred when unpacking the device probably preparing for the procedure meaning that the suture must have been cut and gently removed, however, the evidence shows the contrary with the found issues.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions, since these problems were traced to the user not following the manufacturer's instructions.
Event or Problem Description
It was reported that during unpacking, the stent was found fractured into two parts.The procedure was completed with another of the same device.The patient condition following procedure was stable.

• 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: 20801171
• Report Number: 2124215-2024-75120
• Device Sequence Number: 20806877
• Product Code: FAD
• UDI-Device Identifier: 08714729937791
• UDI-Public: 08714729937791
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: 10/26/2025
• Device Model Number: M0061902130
• Device Catalogue Number: M0061902130
• Device Lot Number: 0030429046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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 Sex: Unknown