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

Model Number M0061902120

Device Problems Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  Injury  

Event 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ureter performed on (b)(6) 2022.During the procedure, the physician placed the stent retrograde, however, the guidewire was retracted for about four centimeters when trying to remove.They used forceps and a dormia basket to pull the stent and place it correctly, and the procedure was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".

Manufacturer Narrative

Initial reporter facility name: hospital san jose sociedad anonima.Initial reporter facility address: 600 oeste del peaje sobre autopista.

Event 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ureter performed on (b)(6) 2022.During the procedure, the physician placed the stent retrograde, however, the guidewire was retracted for about four centimeters when trying to remove.They used forceps and a dormia basket to pull the stent and place it correctly, and the procedure was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".

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
• Type of Device: 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
• MDR Text Key: 303541565
• Report Number: 3005099803-2022-06429
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729937784
• UDI-Public: 08714729937784
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K190603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention