MalfunctionFAD
CONTOUR
Received Jun 8, 2026 · Event occurred May 11, 2026
Report 2124215-2026-30464 · MDR key 25435614
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061802230Catalog number
180-223
Lot number
0038566870
Product problems
- Deformation Due to Compressive Stress
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 USED IN A STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, WHILE INSERTING TO POSITION, IT WAS NOTICED THAT THE STENT WAS BUCKLED/KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL INSIDE THE PATIENT.