MalfunctionHCF
COR KNOT DEVICE
Received Jan 13, 2025 · Event occurred Jan 6, 2025
Report MW5164614 · MDR key 21149131
Device
Generic name
Instrument, Ligature Passing And Knot Tying
Manufacturer
Lsi Solutions Inc.Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
COR-KNOT 4MM DEVICE MALFUNCTIONED DURING MITRAL VALVE REPLACEMENT. NO PATIENT HARM. REP NOTIFIED.