MalfunctionFAD
Contour
Received Jun 8, 2026 · Event occurred Apr 29, 2026
Report 2124215-2026-30387 · MDR key 25429686
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061802230Catalog number
180-223
Lot number
0036938792
Product problems
- Break
- Nonstandard Device
Patient
50 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A TRANSURETHRAL LEFT URETERAL STENTING PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Additional Manufacturer Narrative
BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6). BLOCK H6: DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.