MalfunctionFAD
ASCERTA
Received Jun 26, 2026 · Event occurred May 29, 2026
Report 2124215-2026-34308 · MDR key 25644083
Device
Generic name
Stent, Ureteral
Manufacturer
Boston Scientific CorporationModel number
M0061456130Catalog number
M0061456130
Lot number
0037604234
Product problems
- Break
Patient
NA · Unknown
- 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 AN ASCERTA WAS USED DURING PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. DURING PROCEDURE, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.