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

Model Number	M0061902430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a ureteroscopy procedure in the right ureter, performed on (b)(6) 2023.During preparation, when the suture was removed, the coil of the stent was hurt.Another tria uretral stent was opened and successfully completed the procedure.A photo of the complaint device was provided and showed that the stent shaft was broken.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Medical device problem code a0401 captures the reportable event of stent shaft break.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of stent shaft break.Block h10: the returned tria ureteral stent was analyzed, a photo of the device was attached in the record and a visual evaluation noted that the stent was detached in two sections of the shaft such as in the bladder coil.The positioner was returned in good condition, however, the suture was not returned.A functional analysis was performed and a use of a mandrel of 0,039" passed through stent without resistance.No other problems with the device were noted.The reported event was confirmed.Based on all the relevant information and product analysis, the failure could have been caused due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied during its use and in preparation, these factors could have caused the detachments observed.Consequently, affect the performance of the device.According to the time of event, it occurred preparation, meaning that the suture must have been cut and gently removed, however, the evidence shows the contrary with the found issues.Therefore, failure to follow instructions is selected as the most probable root cause for the complaint since the problem was traced to the user not following the manufacturing instructions.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a ureteroscopy procedure in the right ureter, performed on (b)(6) 2023.During preparation, when the suture was removed, the coil of the stent was hurt.Another tria uretral stent was opened and successfully completed the procedure.A photo of the complaint device was provided and showed that the stent shaft was broken.There were no patient complications reported as a result of this event.

• 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: 16300815
• Report Number: 3005099803-2023-00377
• Device Sequence Number: 6185428
• Product Code: FAD
• UDI-Device Identifier: 08714729937975
• UDI-Public: 08714729937975
• 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): 03/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2024
• Device Model Number: M0061902430
• Device Catalogue Number: 1983-01
• Device Lot Number: 0027548919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/04/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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 Sex: Male