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

Model Number	M0061902210
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a ureteroscopy procedure using a tria ureteral stent, the stent cosmetic at the bladder side was found damaged.Another of the same stent was used to successfully complete the procedure.No patient complications were noted.
Additional Manufacturer Narrative
Block h6: device problem code a0203 captures the reportable event of stent damage inside the patient.
Additional Manufacturer Narrative
Block h6: device problem code a0203 captures the reportable event of stent damage inside the patient.Block h11: the returned tria firm ureteral stent was analyzed, and the evaluation found with suture hole and the tip torn.Additionally, the suture did not return.During magnification, it was observed closely that the suture hole and the tip torn.Based on the most relevant information, the device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported problem.During product analysis it was observed that the suture hole and the bladder tip was torn, evidence of "device damage defective (suture hole torn and stent tip torn".It is possible to concluded that this problem could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get "torn" during the procedure affecting the performance of the device.Based on the analysis results, 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 that, during a ureteroscopy procedure using a tria ureteral stent, the stent cosmetic at the bladder side was found damaged.Another of the same stent was used to successfully complete the procedure.No patient complications were noted.

• 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: 19533422
• Report Number: 2124215-2024-35746
• Device Sequence Number: 12649812
• Product Code: FAD
• UDI-Device Identifier: 08714729937838
• UDI-Public: 08714729937838
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 10/11/2024

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 Model Number: M0061902210
• Device Catalogue Number: 1983-01
• Device Lot Number: 0032653786
• 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: 05/19/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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: Male