MalfunctionFAD
TRIA? SOFT
Received Apr 29, 2026 · Event occurred Apr 2, 2026
Report 2124215-2026-23130 · MDR key 25032239
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061903230Catalog number
M0061903230
Lot number
0037845830
Product problems
- Detachment of Device or Device Component
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF COIL DETACHED INSIDE THE PATIENT.
Description of Event or Problem
IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A RETROGRADE INTRARENAL SURGERY PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE END OF THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.