MalfunctionFAD
POLARIS? ULTRA
Received May 28, 2026 · Event occurred Feb 9, 2026
Report 2124215-2026-28770 · MDR key 25325158
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061921230Catalog number
M0061921230
Lot number
0035790852
Product problems
- Unsealed Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A020503 CAPTURES THE REPORTABLE EVENT OF CONTAMINATION OF SEAL COMPROMISED.
Description of Event or Problem
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS CONTAMINATED. THERE WAS NO INFORMATION ON WHAT HAVE COMPLETED THE PROCEDURE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR POLARIS ULTRA URETERAL STENT USED IN THE SAME PROCEDURE.