ENROUTE Transcarotid Neuroprotection System
Received Jul 30, 2026 · Event occurred Apr 16, 2026
Report 2124215-2026-40924 · MDR key 50085704
Device
Generic name
Embolic Protection Filtering Guidewire
Manufacturer
Silk Road MedicalModel number
FG12531Catalog number
FG12531
Lot number
0000306232
Product problems
- Degraded
Patient
83 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported the numerical markings 1, 2, and 3 were not present on the arterial sheath prior to the procedure. An ENROUTE Transcarotid Neuroprotection System was selected for use in a Transcarotid Artery Revascularization (TCAR) procedure. Upon removal of the sheath stopper for tunneling and before the arterial sheath was inserted into the patient, it was observed that the numerical pad-printed markings 1, 2, and 3 were not present on the sheath. The procedure was completed with the same device with no reported patient complications. No evidence of flaking was observed. The patient was stable post procedure.