MalfunctionFAD
TRIA? SOFT
Received Apr 21, 2026 · Event occurred Mar 23, 2026
Report 2124215-2026-21636 · MDR key 24947743
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061903200Catalog number
M0061903200
Lot number
0037265713
Product problems
- Break
- Nonstandard Device
Patient
43 YR · 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 PROCEDURE, A TRIA SOFT URETERAL STENT WAS INTENDED TO BE USED. DURING THE PREPARATION, WHEN THE DEVICE WAS OPENED, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.