MalfunctionFAD
TRIA? FIRM
Received Apr 14, 2026 · Event occurred Mar 18, 2026
Report 2124215-2026-20205 · MDR key 24879262
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061902320Catalog number
M0061902320
Lot number
0035615483
Product problems
- Break
- Nonstandard Device
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.
Description of Event or Problem
IT WAS REPORTED THAT DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE A TRIA URETERAL STENT WAS INTENDED TO BE USED; HOWEVER, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE NOTED.