MalfunctionFAD
TRIA? FIRM
Received Apr 20, 2026 · Event occurred Mar 19, 2026
Report 2124215-2026-21419 · MDR key 24933924
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061902410Catalog number
M0061902410
Lot number
0037617570
Product problems
- Break
- Nonstandard Device
- Detachment of Device or Device Component
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A TRIA URETERAL STENT WAS TO BE USED IN A RETROGRADE INTRARENAL SURGERY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.