POLARIS? ULTRA
Received Jun 30, 2026 · Event occurred Jun 3, 2026
Report 2124215-2026-34893 · MDR key 25673461
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061921210Catalog number
M0061921210
Lot number
0037950911
Product problems
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF DEVICE FOREIGN MATERIAL PRESENT IN DEVICE.
Description of Event or Problem
IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED IN A URETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THERE WAS A FOREIGN MATTER INSIDE THE TUBE OF THE STENT AND COULD NOT BE INSERTED. NO FOREIGN MATTER FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.