POLARIS? ULTRA
Received Jun 26, 2026 · Event occurred May 28, 2026
Report 2124215-2026-34012 · MDR key 25638461
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061921320Catalog number
M0061921320
Lot number
0036113896
Product problems
- Difficult to Remove
- Deformation Due to Compressive Stress
- Detachment of Device or Device Component
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. DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF COIL DETACHED INSIDE THE PATIENT.
Description of Event or Problem
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN URETEROSCOPY FLEX PROCEDURE IN THE KIDNEY. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WAS DIFFICULT TO PLACE ALONG THE GUIDEWIRE AND THE DISTAL END OF THE STENT WAS NOTICED TO BE BROKEN. THE STENT WAS FULLY REMOVED AND SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PICTURE PROVIDED BY THE CUSTOMER SHOWED THAT THE STENT WAS ALSO BUCKLED