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

Model Number	M0061903240
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the ureteroscopy procedure, a tear was found in the stent.The procedure was completed with another of the same device and no patient complications.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent-torn material, inside the patient.
Additional Manufacturer Narrative
Imdrf device code a0414 captures the reportable event of stent-torn material, inside the patient.The returned tria ureteral stent was analyzed, and upon magnification it was observed that the bladder coil was torn.Additionally, the suture and positioner were not returned.The reported event was confirmed.With all the available information, boston scientific concludes that the reported event was confirmed.It is possible to concluded that this problem could be caused by operational factors, the retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force and for the way that the device was pulled out the bladder coil may get the coil hole torn, during the preparation affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions since the adverse event occurred during the preparation and the device had no influence on event.
Event or Problem Description
It was reported that during the ureteroscopy procedure, a tear was found in the stent.The procedure was completed with another of the same device and no patient complications.

• 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: 19400166
• Report Number: 2124215-2024-30322
• Device Sequence Number: 8299454
• Product Code: FAD
• UDI-Device Identifier: 08714729959915
• UDI-Public: 08714729959915
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: M0061903240
• Device Catalogue Number: 1983-02
• Device Lot Number: 0032867154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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