MalfunctionFAD
CONTOUR
Received Jun 23, 2026 · Event occurred May 17, 2026
Report 2124215-2026-33308 · MDR key 25600517
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061802230Catalog number
180-223
Lot number
0036785878
Product problems
- Deformation Due to Compressive Stress
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF DEFORMATION DUE TO COMPRESSIVE STRESS.
Description of Event or Problem
IT WAS REPORTED THAT A CONTOUR STENT WAS USED DURING TRANSURETHRAL URETERAL STENTING PROCEDURE. DURING PROCEDURE, WHILE IN THE PROCESS OF PLACING THE URETER IT WAS FOUND THAT THE PRODUCT FOLDS AND WAS NOT PLACED SMOOTHLY THEREFORE, IT COULD NOT BE PLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.