MalfunctionFAD
CONTOUR VL?
Received Apr 24, 2026 · Event occurred Mar 26, 2026
Report 2124215-2026-22468 · MDR key 24990257
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061801560Catalog number
M0061801560
Lot number
0035284289
Product problems
- Difficult to Advance
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK E1: INITIAL REPORTER CITY - (B)(6). BLOCK H6: DEVICE CODE A0414 CAPTURES THE REPORTABLE EVENT OF STENT TORN MATERIAL INSIDE THE PATIENT.
Description of Event or Problem
IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE URETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE STENT, IT WAS NOTICED THAT THE STENT WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.