MalfunctionFAD
POLARIS? ULTRA
Received Apr 11, 2026 · Event occurred Mar 13, 2026
Report 2124215-2026-19648 · MDR key 24852615
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061921220Catalog number
M0061921220
Lot number
0031218312
Product problems
- Obstruction of Flow
- Difficult to Advance
Patient
50 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6). BLOCK H6: IMDRF DEVICE CODE A1409 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION OF FLOW.
Description of Event or Problem
IT WAS REPORTED THAT DURING A URETEROSCOPY INTERVENTION PROCEDURE, A POLARIS ULTRA URETERAL STENT WAS INTENDED TO BE USED. DURING PREPARATION, IT WAS FOUND THAT THE INDWELLING WAS UNSUCCESSFUL AND THE LUMEN WAS BLOCKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.