POLARIS? LOOP
Received Jun 16, 2026 · Event occurred May 19, 2026
Report 2124215-2026-31993 · MDR key 25516759
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061552320Catalog number
M0061552320
Lot number
0037374087
Product problems
- Difficult to Advance
- Material Deformation
Patient
Not reported
- 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 LOOP URETERAL STENT WAS USED IN A URETERAL DILATATION PROCEDURE IN THE RIGHT KIDNEY. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE GUIDEWIRE WAS BLOCKED THROUGH THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT HAD KINKS.