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

Model Number	M0061903250
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	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that a tria ureteral stent was opened to be used in an unspecified procedure on an unknown date.During preparation, it was noted that the stent was broken into two pieces.The procedure was successfully completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6), 2023, as no event date was reported.Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to may 1, 2023, as no event date was reported.Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.The returned tria ureteral stent was analyzed, and a visual evaluation noted that the bladder coil was detached.Their suture, positioner and detached part was not returned.Functional test was performed and a use of mandrel 0.039" passed through the stent without resistance.The reported event of stent shaft break was not confirmed.A breakage was not detected upon analysis; however, it was found that the stent's bladder coil was detached.Additionally, the suture did not return indicating it was removed and the stent was used.Based on the most relevant information of the complaint event description, 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.According to the evidence, it is possible that 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 that was observed.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 or Problem Description
It was reported to boston scientific that a tria ureteral stent was opened to be used in an unspecified procedure on an unknown date.During preparation, it was noted that the stent was broken into two pieces.The procedure was successfully completed with another of the same device.There were no patient complications reported as a result of this event.The device has not been returned for analysis.

• 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: 17060224
• Report Number: 3005099803-2023-02880
• Device Sequence Number: 18287006
• Product Code: FAD
• UDI-Device Identifier: 08714729953968
• UDI-Public: 08714729953968
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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: 02/07/2026
• Device Model Number: M0061903250
• Device Catalogue Number: 1983-02
• Device Lot Number: 0031012358
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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: Unknown