MalfunctionFAD
TRIA? SOFT
Received Apr 14, 2026 · Event occurred Mar 12, 2026
Report 2124215-2026-20005 · MDR key 24868060
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061903220Catalog number
M0061903220
Lot number
0036752342
Product problems
- Break
- Nonstandard Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.
Description of Event or Problem
IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT BROKE. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE WAS THERE WERE NO PATIENT COMPLICATIONS REPORTED.