MalfunctionFAD
POLARIS? ULTRA
Received Apr 15, 2026 · Event occurred Mar 20, 2026
Report 2124215-2026-20269 · MDR key 24880945
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061921330Catalog number
M0061921330
Lot number
0036586099
Product problems
- Break
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK. THIS EVENT WAS REPORTED BY THE DISTRIBUTOR. THE HEALTH CARE FACILITY IS: (B)(6) HOSPITAL. PHONE: (B)(6). NO. (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS TO BE USED IN A LITHOTOMY PROCEDURE. 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.