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

Model Number M0061903430

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a040601 captures the reportable event of stent buckled material, inside the patient.

Event 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.

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 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
• 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: 18965202
• MDR Text Key: 338437606
• Report Number: 2124215-2024-15871
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729959984
• UDI-Public: 08714729959984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/23/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• 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