MalfunctionFAD
TRIA SOFT
Received May 18, 2026 · Event occurred Apr 17, 2026
Report 2124215-2026-26842 · MDR key 25211580
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M006190323090Catalog number
1983-03
Lot number
0038213085
Product problems
- Break
- Nonstandard Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: 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 TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.