MalfunctionFAD
POLARIS? ULTRA
Received Apr 14, 2026 · Event occurred Mar 11, 2026
Report 2124215-2026-20036 · MDR key 24872686
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061921230Catalog number
M0061921230
Lot number
0036623654
Product problems
- Break
Patient
26 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.
Description of Event or Problem
IT WAS REPORTED THAT DURING A TRANSURETHRAL URETERAL STENTING PROCEDURE, A POLARIS ULTRA URETERAL STENT WAS TO BE USED. AFTER UNPACKING, IT WAS FOUND THAT THE DJ CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.