MalfunctionFAD
POLARIS? ULTRA
Received May 22, 2026 · Event occurred Apr 22, 2026
Report 2124215-2026-27882 · MDR key 25263120
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061921330Catalog number
M0061921330
Lot number
0036855502
Product problems
- Break
Patient
44 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(6). BLOCK H6: DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.
Description of Event or Problem
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A LITHOTRIPSY PROCEDURE IN THE URETER. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.