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

Model Number	M0061902320
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a tria firm uereral stent was used during a ureteroscopy procedure in the left ureter, performed on (b)(6)2022.During the procedure, the stent could not be inserted in the ureter.It was noticed that the lumen is not in normal condition.Another tria firm ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of stent kinked.
Additional Manufacturer Narrative
Medical problem code a0406 captures the reportable investigation result of stent kinked inside the patient.The returned tria firm ureteral stent was analyzed, and a visual evaluation noted that the renal pig tail kink, after that, was possible observed both coils in good conditions with their respective revolution.Additionally, the suture and positioner did not return.During functional analysis use a mandrel of 0,039" and pass through stent without resistance.A photo of the device shows that the device was out of its original pouch where is possible observed only the stent without their suture, no caught any other abnormality.No other issues with the device were noted.The reported event was not confirmed.According to the product analysis, it is possible that operational factors, manipulation of the device with excess of force applied during it use in the procedure, could have caused the kink in the renal coil.Consequently, affect the performance of the device.After a functional, visual, magnification and dimensional test in the complaint device it was not possible to identify evidence or any defect on the device related with the alleged issue.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15261813
• Report Number: 3005099803-2022-04562
• Device Sequence Number: 12428170
• Product Code: FAD
• UDI-Device Identifier: 08714729937906
• UDI-Public: 08714729937906
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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: 06/21/2024
• Device Model Number: M0061902320
• Device Catalogue Number: 1983-01
• Device Lot Number: 0027538539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/19/2022
• Date Device Manufactured: 06/22/2021
• 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: 68 YR
• Patient Sex: Female