inforMED
MalfunctionHCF

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

Model number

031350

Catalog 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.