COR-KNOT MINI®
Received Nov 14, 2025 · Event occurred Sep 16, 2025
Report 23554375 · MDR key 23554375
Device
Generic name
Instrument, Ligature Passing And Knot Tying
Manufacturer
Lsi Solutions, Inc.Model number
031350Catalog number
031350
Lot number
8631477
Product problems
- Failure to Cut
- Failure to Fire
Patient
60 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED ON THE TABLE IN THE SUPINE POSITION. GENERAL ANESTHESIA WAS INDUCED; LINES AND MONITORING DEVICES WERE PLACED. PATIENT'S CHEST WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. WHEN IT WAS TIME TO DO THE AVR [AORTIC VALVE REPLACEMENT], THE AORTIC VALVE WAS INSPECTED AND THERE APPEARED TO BE A CALCIFIED LESION DISTORTING THE RIGHT CORONARY LEAFLET. NEAR THE END OF THE AVR, SUTURES WERE PLACED THROUGH THE SEWING CUFF OF THE VALVE AND FASTENED IN PLACE USING COR-KNOTS. HOWEVER, THE FIRING MECHANISM STOPPED AT 8 AND IT STOPPED CUTTING WIRE. THE DEVICE WAS EXCHANGED FOR ANOTHER ONE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. NO PATIENT HARM.