MalfunctionFAD
CONTOUR
Received May 20, 2026 · Event occurred Mar 18, 2026
Report 2124215-2026-27122 · MDR key 25226481
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061802220Catalog number
180-222
Lot number
0036802164
Product problems
- Break
- Difficult to Advance
Patient
57 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT SHAFT BREAK.
Description of Event or Problem
IT WAS REPORTED THAT, DURING THE REMOVAL OF KIDNEY STONES PROCEDURE, A CONTOUR URETERAL STENT WAS INTENDED TO BE USED. UPON UNPACKING, IT WAS FOUND THAT THE FRONT END OF THE STENT ADHERED AND THE MIDDLE PART WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.