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

Model Number	M0061902130
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code (b)(6) captures the reportable investigation results of stent buckled material, inside the patient.Block h10: the returned tria firm ureteral stent was analyzed, and a visual and microscopic evaluation noted that both coils were buckled and torn, including the tips.The mandrel 0.036 was loaded into the device and no resistance was felt, however, the returned device evidence noted that it was difficult to implant.No other problems with the device were noted.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is possible to conclude that this problem could be caused by operational factors, such as interaction of the device between the positioner and the guide wire.It's possible to conclude that due to the buckle and torn found in the device coils and tips, this could have been generated because the physician could have difficulties during the preparation, in order to place the device in the target, leading the physician to use an excess of force in the placement of the device leading the device to be buckled and torn.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a tria firm ureteral stent was used to treat kidney stones during a flexible ureteral lithotripsy procedure in the kidney performed on (b)(6) 2023.During the procedure, it was noted that the stent was difficult to implant.The procedure was completed with another tria firm ureteral stent and there were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Account mentions on (b)(6) 2024 stent was placed in the patient therefore this event has been deemed an mdr reportable event.Investigation results revealed that the stent was buckled, please see block h10 for full investigation details.

• 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: 18754460
• Report Number: 2124215-2024-09437
• Device Sequence Number: 3838111
• 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
• Report Date (Section B): 02/21/2024

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: 06/08/2025
• Device Model Number: M0061902130
• Device Catalogue Number: 1983-01
• Device Lot Number: 0029562372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 75 KG