MalfunctionNTE
ENROUTE Transcarotid Neuroprotection System
Received Jul 30, 2026 · Event occurred Jul 7, 2026
Report 2124215-2026-41110 · MDR key 50093022
Device
Generic name
Embolic Protection Filtering Guidewire
Manufacturer
Silk Road MedicalModel number
FG12531Catalog number
FG12531
Lot number
0000307148
Product problems
- Fluid/Blood Leak
Patient
70 YR · Unknown
- Hemorrhage/Blood Loss/Bleeding