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

Model Number	M0061903430
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of stent buckled material, inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that a tria soft ureteral stent was used during a ureteroscopy procedure in the ureter performed on (b)(6) 2024.During insertion, when the stent was being inserted into the ureter using the enclosed pusher, the stent was found buckled.The procedure was successfully completed with another tria soft ureteral stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of stent buckled material, inside the patient.Block h10: the returned tria ureteral stent was analyzed, and a visual and microscopic evaluation noted that the bladder coil buckled.Additionally, the suture and positioner were not returned.No other problems with the device were noted.The reported event was confirmed.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.Interaction of the device between the positioner and the guide wire while the device was pushing up, such as excess of force applied over the device during the procedure could have contributed to the problem, consistently leading to device being buckled and torn.Consequently, affect the performance of the device.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.
Event or Problem Description
It was reported to boston scientific corporation that a tria soft ureteral stent was used during a ureteroscopy procedure in the ureter performed on (b)(6) 2024.During insertion, when the stent was being inserted into the ureter using the enclosed pusher, the stent was found buckled.The procedure was successfully completed with another tria soft ureteral stent.There were no patient complications reported as a result of this event.

• Brand Name: TRIA SOFT
• 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: 18965202
• Report Number: 2124215-2024-15871
• Device Sequence Number: 7965786
• Product Code: FAD
• UDI-Device Identifier: 08714729959984
• UDI-Public: 08714729959984
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: 10/26/2025
• Device Model Number: M0061903430
• Device Catalogue Number: 1983-02
• Device Lot Number: 0030429040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 05/07/2024
• 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