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

Model Number	M0061902130
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device problem code a0413 captures the reportable event of stent buckled.Impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported that, during a percutaneous nephrolithotomy procedure, using a tria ureteral stent, the stent became buckled multiple times over the guidewire.Additionally, the radiopaque marker of the pusher was separated and was floating around the kidney and had to be retrieved with grasping forceps.Another of the same stent was used to complete the procedure.No further patient complications were reported.
Additional Manufacturer Narrative
Block h6: device problem code a0413 captures the reportable event of stent buckled.Impact code f23 captures the reportable event of unexpected medical intervention.Block h11: correction to field block h6: device codes.
Event or Problem Description
It was reported that, during a percutaneous nephrolithotomy procedure, using a tria ureteral stent, the stent became buckled multiple times over the guidewire.Additionally, the radiopaque marker of the pusher was separated and was floating around the kidney and had to be retrieved with grasping forceps.Another of the same stent was used to complete the procedure.No further patient complications were reported.

• Brand Name: TRIA FIRM
• 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: 20139328
• Report Number: 2124215-2024-55156
• Device Sequence Number: 3187519
• Product Code: FAD
• UDI-Device Identifier: 08714729937791
• UDI-Public: 08714729937791
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K190603
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061902130
• Device Catalogue Number: 1983-01
• Device Lot Number: 0033925645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/11/2024
• Date Device Manufactured: 04/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown