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

Model Number	M0061903250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned tria ureteral stent was analyzed, and a visual evaluation noted that the middle section of the stent was detached/separated.The suture string was returned loaded and cut in the device.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the middle section of the ureteral stent was detached/separated.Additionally, the picture provided by the complainant showed the stent shaft detached at the middle section.According to product analysis, the issue occurred during unpacking, the problem found is an issue that could have been generated by the user or due to the interacting of the device with the suture string.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during preparation and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a ureteroscopy and stent placement procedure in the kidney, ureter, bladder, performed on (b)(6) 2021.During unpacking, the stent broke in two.Another tria ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.A photo of the complaint device was provided and showed that the stent shaft was broken in two.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a ureteroscopy and stent placement procedure in the kidney, ureter, bladder, performed on (b)(6) 2021.During unpacking, the stent broke in two.Another tria ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.A photo of the complaint device was provided and showed that the stent shaft was broken in two.
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, and a visual evaluation noted that the middle section of the stent was detached/separated.The suture string was returned loaded and cut in the device.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the middle section of the ureteral stent was detached/separated.Additionally, the picture provided by the complainant showed the stent shaft detached at the middle section.According to product analysis, the issue occurred during unpacking, the problem found is an issue that could have been generated by the user or due to the interacting of the device with the suture string.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during preparation and the device had no influence on the event.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 SOFT
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11607372
• Report Number: 3005099803-2021-01426
• Device Sequence Number: 16966895
• Product Code: FAD
• UDI-Device Identifier: 08714729953968
• UDI-Public: 08714729953968
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 10/23/2023
• Device Model Number: M0061903250
• Device Catalogue Number: 1983-02
• Device Lot Number: 0026242128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1