MalfunctionDQY
ZEBRA
Received Jan 7, 2026 · Event occurred Oct 8, 2025
Report 23989749 · MDR key 23989749
Device
Generic name
Catheter, Percutaneous
Manufacturer
Q'apel Medical, IncModel number
AC6074-095-30Catalog number
AC6074-095-30
Lot number
FG250806C-01
Patient
NA · Male
- Foreign Body In Patient
Narrative
Description of Event or Problem
A VASCULAR CATHETER WAS THREADED THROUGH AN AORTIC STENT, AND THE CATHETER TIP WAS SHEARED OFF AND RETAINED WITHIN STENT AFTER TREATMENT.