inforMED
MalfunctionHCF

COR-KNOT MINI

Received Oct 1, 2024 · Event occurred Sep 4, 2024

Report 20343944 · MDR key 20343944

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Model number

031350

Catalog number

031350

Lot number

2463371-2

Patient

70 YR · Male

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

Narrative

Description of Event or Problem

ELDERLY MALE WITH HISTORY OF MULTIVESSEL CORONARY ARTERY DISEASE AND ABNORMAL STRESS TEST WITH SUSPECTED AORTIC STENOSIS. UNDERWENT CORONARY ARTERY BYPASS GRAFT X 4 WITH AORTIC VALVE REPLACEMENT. DURING PROCEDURE, ONE OF THE COR-KNOT DEVICES DID NOT RELEASE THE SUTURE AFTER FIRING. THE SUTURE NEEDED TO BE CUT AND A NEW STITCH HAD TO BE PLACED. NO KNOWN HARM TO THE PATIENT.