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

Model Number M0061902910

Device Problems Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 11/03/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0414 captures the reportable event of stent torn, inside the patient.Imdrf device code 1069 captures the reportable event of stent material deformation, inside the patient.Block h10: the returned tria firm ureteral stent was analyzed, and a visual evaluation noted that the bladder coil was buckled or accordion and the bladder tip was torn.A functional test was performed in order to discard any failure related to difficult to advance.No other problems with the device were noted.Taking all available information into consideration, most likely, device analysis and including the product record review results, 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.Excess force applied over the device during the procedure could have contribute to the problem, consistently leading to device being buckled, accordion and torn.Consequently, affect the performance of the device.Therefore, the most probable root cause is adverse event related to the procedure.

Event Description

A tria firm ureteral stent was returned to boston scientific corporation.This product was returned together with another tria firm ureteral stent under tw (b)(4), to the manufacturer without any report of performance issues or adverse patient effects.This event has been deemed reportable based on the investigation results of stent buckled and torn, inside the patient.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: 18292108
• MDR Text Key: 330260395
• Report Number: 2124215-2023-68216
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2023

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
• Device Operator: Health Professional
• Device Model Number: M0061902910
• Device Catalogue Number: 1983-01
• Device Lot Number: 0030680050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2022
• 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