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

Model Number M0061902130

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 336762640
• Report Number: 2124215-2024-09437
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K190603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 75 KG