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

Model Number	M0061903220
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf a0501 captures the reportable investigation results of stent shaft break.: the tria ureteral stent has been returned and during inspection it was found that the shaft of the stent was detached with the suture hole and the bladder coil tip were found torn.Moreover, the suture returned cut and the positioner did not return.The reported event of coil detachment was not confirmed.However, the stent was found with the shaft detached.It is possible to conclude that this issue could be caused by the suture was not gently pulled out and consequently affects the performance of the device.The instructions for use contains detailed device information and instructions for the device use.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions since problems traced to the user not following the manufacturer's instructions.
Event or Problem Description
It was reported that during the ureteroscopy preparation, while the device was still outside the patient, it was noticed that the coil of the tria soft ureteral stent was detached when the suture was removed.The procedure was completed using another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that during preparation, outside the patient, it was noticed that the coil of the stent was detached when the suture was removed.The procedure was completed using another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf a0501 captures the reportable investigation results of stent shaft break.Block h11: the tria ureteral stent has been returned and during inspection it was found that the shaft of the stent was detached with the suture hole and the bladder coil tip were found torn.Moreover, the suture returned cut and the positioner did not return.The reported event of coil detachment was not confirmed.However, the stent was found with the shaft detached.It is possible to conclude that this issue could be caused by the suture was not gently pulled out and consequently affects the performance of the device.The instructions for use contains detailed device information and instructions for the device use.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions since problems traced to the user not following the manufacturer's instructions.The labeling review found evidence to suggest that the device was used in a manner inconsistent with the labelled indications.Remove retrieval line by holding the knot, cutting one strand, and while holding the knot, gently pull on the retrieval line.The guidewire is then removed, stabilizing the stent with positioner.However, was found with the shaft detached, and also the suture hole and the bladder coil tip were found torn.Additionally, the suture returned cut and loaded.These failures could be evidence that the suture was not gently pulled out.The indication for use, contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu or labeling information.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20907077
• Report Number: 2124215-2024-78138
• Device Sequence Number: 21120982
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: 08714729959892
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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 Model Number: M0061903220
• Device Catalogue Number: 1983-02
• Device Lot Number: 0033243377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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: Female