POLARIS? LOOP
Received Apr 22, 2026 · Event occurred Feb 18, 2026
Report 2124215-2026-21782 · MDR key 24956094
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061552320Catalog number
M0061552320
Lot number
0033875977
Product problems
- Deformation Due to Compressive Stress
- Difficult to Advance
Patient
63 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6). 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 LOOP URETERAL STENT WAS USED IN A RIGID URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE RIGHT RENAL PELVIS. DURING INSERTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. PICTURE PROVIDED BY THE CUSTOMER SHOWED THAT THE STENT WAS BUCKLED.