inforMED
MalfunctionHCF

COR-KNOT MINI®

Received Dec 9, 2025 · Event occurred Oct 10, 2025

Report 23756431 · MDR key 23756431

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Model number

031350

Catalog number

031350

Lot number

8329889

Product problems

  • Failure to Fire
  • Material Split, Cut or Torn

Patient

55 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WHEN ATTEMPTING TO DEPLOY THE COR-KNOT ON A VALVE SUTURE, THE COR-KNOT DID NOT DEPLOY FROM THE DEVICE AND ONLY CUT THE SUTURE. THE MALFUNCTIONING PIECES WERE REMOVED FROM THE FIELD.