MalfunctionFAD
POLARIS? LOOP
Received Apr 21, 2026 · Event occurred Mar 24, 2026
Report 2124215-2026-21430 · MDR key 24947744
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061552310Catalog number
M0061552310
Lot number
0032106131
Product problems
- Break
Patient
56 YR · Male
- 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 LITHOTRIPSY FOR LEFT RENAL CALCULI, A POLARIS URETERAL STENT WAS TO BE USED. AFTER UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED INTO TWO PARTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.