MalfunctionFAD
POLARIS? ULTRA
Received Apr 14, 2026 · Event occurred Mar 17, 2026
Report 2124215-2026-20016 · MDR key 24868488
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061921240Catalog number
M0061921240
Lot number
0037312115
Product problems
- Deformation Due to Compressive Stress
- Difficult to Advance
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL 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, THE STENT WAS NOT GOING OVER THE WIRE AND IT WAS NOTICED THAT IT WAS BUCKLING AT THE URETERAL OPENING. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.