MalfunctionHCF
COR-KNOT MINI
Received Oct 22, 2024 · Event occurred Sep 16, 2024
Report 20504603 · MDR key 20504603
Device
Generic name
Instrument, Ligature Passing And Knot Tying
Manufacturer
Lsi Solutions, Inc.Model number
031350Catalog number
031350
Lot number
4366271
Patient
2 MO · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
> 60-YEAR-OLD MALE WITH HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, GUILLIAN-BARRE AND RECENT ABNORMAL STRESS TEST. PATIENT UNDERWENT CORONARY ARTERY BYPASS SURGERY WITH AORTIC VALVE REPLACEMENT AND MITRAL VALVE REPLACEMENT. DURING SURGERY COR-KNOT DEVICE GOT STUCK WHILE TRYING TO USE IT. NO KNOWN HARM TO THE PATIENT.