POLARIS? ULTRA
Received Apr 14, 2026 · Event occurred Mar 17, 2026
Report 2124215-2026-20131 · MDR key 24876145
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061921320Catalog number
M0061921320
Lot number
0035639001
Product problems
- Deformation Due to Compressive Stress
Patient
40 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK A1: PATIENT IDENTIFIER: (B)(6). BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) UNIVERSITY. BLOCK H6: DEVICE CODE (B)(6) 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 LITHOTRIPSY PROCEDURE IN THE KIDNEY. DURING INTRODUCTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS WRINKLED AND COULD NOT BE PUSHED IN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.