MalfunctionFAD
POLARIS? ULTRA
Received Apr 14, 2026 · Event occurred Mar 17, 2026
Report 2124215-2026-20076 · MDR key 24874550
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061921250Catalog number
M0061921250
Lot number
0037257489
Product problems
- Difficult to Advance
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT KINKED INSIDE THE PATIENT.
Description of Event or Problem
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WAS NOT FEEDING OVER THE WIRE AND WAS CRIMPED AT THE URETERAL OPENING. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.