MalfunctionFAD
POLARIS? LOOP
Received Jul 6, 2026 · Event occurred Jun 8, 2026
Report 2124215-2026-36169 · MDR key 25728099
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061552330Catalog number
M0061552330
Lot number
0036890801
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6). BLOCK H6: DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.
Description of Event or Problem
IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS TO BE USED IN A LASER LITHOTRIPSY UNDER RIGHT URETEROSCOPE PROCEDURE. DURING UNPACKING, WHEN THE PHYSICIAN PULLED THE STENT OUT, IT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.