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

Model Number	M0061902120
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a percutaneous nephrolithotomy procedure in the right kidney and proximal ureter performed on (b)(6) 2022.During the procedure, the physician placed the stent retrograde, however, the guidewire was retracted for about four centimeters when trying to remove.They used forceps and a dormia basket to pull the stent and place it correctly, and the procedure was successfully completed with the original tria ureteral stent.There were no patient complications reported however, an additional intervention was required.The patient's condition at the conclusion of the procedure was reported to be "expected to fully recover".
Additional Manufacturer Narrative
Initial reporter facility name: hospital san jose sociedad anonima.Initial reporter facility address: 600 oeste del peaje sobre autopista.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used during a percutaneous nephrolithotomy procedure in the right kidney and proximal ureter performed on (b)(6) 2022.During the procedure, the physician placed the stent retrograde, however, the guidewire was retracted for about four centimeters when trying to remove.They used forceps and a dormia basket to pull the stent and place it correctly, and the procedure was successfully completed with the original tria ureteral stent.There were no patient complications reported however, an additional intervention was required.The patient's condition at the conclusion of the procedure was reported to be "expected to fully recover".
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Initial reporter facility address: (b)(6).Block h6: patient impact code f12 captures the reportable event of additional intervention required.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15777072
• Report Number: 3005099803-2022-06429
• Device Sequence Number: 20052103
• Product Code: FAD
• UDI-Device Identifier: 08714729937784
• UDI-Public: 08714729937784
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K190603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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 Expiration Date: 04/20/2025
• Device Model Number: M0061902120
• Device Catalogue Number: 1983-01
• Device Lot Number: 0029264749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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