MalfunctionDRE

PEDIASAT

Received Jul 27, 2026

Report 2015691-2026-17184 · MDR key 50045971

Device

Generic name

Dilator, Vessel, For Percutaneous Catheterization

Manufacturer

Edwards Lifesciences, Pr

Model number

Product problems

Fluid/Blood Leak
Gas/Air Leak

Patient

Unknown

No Clinical Signs, Symptoms or Conditions