MalfunctionFAD
CONTOUR
Received Apr 29, 2026 · Event occurred Apr 6, 2026
Report 2124215-2026-23202 · MDR key 25034501
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061802440Catalog number
180-244
Lot number
0037572380
Product problems
- Break
- Material Deformation
Patient
NA · Unknown
- 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 PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE END OF THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.