MalfunctionEZB
AMPLATZ SUPER STIFF
Received Jun 5, 2026 · Event occurred Mar 4, 2026
Report 2124215-2026-30262 · MDR key 25416628
Device
Generic name
Stylet For Catheter, Gastro-urology
Manufacturer
Boston Scientific CorporationModel number
M0066401081Catalog number
640-108
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 CORE WIRE BREAK.
Description of Event or Problem
IT WAS REPORTED THAT A AMPLATZ - URO WAS USED DURING URETEROSCOPY PROCEDURE. DURING PROCEDURE IT WAS FOUND THAT THE WIRE WAS BROKEN OFF AND LEFT INSIDE THE PATIENT. THE BROKEN WIRE WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE REQUIRES ADDITIONAL INTERVENTION, AND THE PATIENT REQUIRES ADDITIONAL HOSPITAL VISIT.