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

Model Number	M0061903320
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that a tria soft ureteral stent was to be used during a retrograde intrarenal surgery procedure in the kidney stone, performed on (b)(6) 2023.During preparation, when the device was checked, it was noted that the stent was broken along the shaft.Another tria ureteral stent was opened and used 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported to boston scientific that a tria soft ureteral stent was to be used during a retrograde intrarenal surgery procedure in the kidney stone, performed on (b)(6) 2023.During preparation, when the device was checked, it was noted that the stent was broken along the shaft.Another tria ureteral stent was opened and used 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.
Additional Manufacturer Narrative
Block h6: imdrf device 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 shaft was detached.A photo of the device was provided, and it was also observed that the stent was detached, and a portion of the suture was partially visible.The positioner was returned in good condition and the suture was returned loaded and uncut.It was observed that the suture hole was torn.For the functional analysis, a mandrel of 0,039" passed through the stent without resistance.During magnification, the found issues were closely observed.It was also observed that a side port hole of the shaft and the side port holes of the bladder coil was kinked.The reported event was confirmed.Based on all the gathered information and device analysis, it is possible to conclude that some operational factors, interaction of the excess force during interaction with the suture string such as an entanglement before their use could have caused the detachment and the torn that were observed.Consequently, this affects the performance of the device.For the side port holes of the shaft and bladder coil was bent/kinked, most likely these failures could have been generated during the preparation during the setting up, probably some excess of force was applied over the device such as the handling or operational factors between the device and the guide wire that caused the failure.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.

• Brand Name: TRIA SOFT
• 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: 16704502
• Report Number: 3005099803-2023-01763
• Device Sequence Number: 20263723
• Product Code: FAD
• UDI-Device Identifier: 08714729959939
• UDI-Public: 08714729959939
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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: 04/22/2024
• Device Model Number: M0061903320
• Device Catalogue Number: 1983-02
• Device Lot Number: 0027196214
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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: 49 YR
• Patient Sex: Female