MalfunctionHCF

COR-KNOT MINI

Received Sep 19, 2024 · Event occurred Feb 28, 2024

Report 20255687 · MDR key 20255687

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Manufacturer

Lsi Solutions, Inc.

Model number

031350

Catalog number

031350

Lot number

2255324

Patient

2 MO · Male

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

Narrative

Description of Event or Problem

PATIENT UNDERGOING REPAIR OF ASCENDING AORTA, MINI COR-KNOT USED FOR THE KONNECT VALVE. COR-KNOT DEVICE LOADED AND TIGHTENED ON VALVE SUTURES AND THE DEVICE IS NOT CUTTING. TRIED MULTIPLE TIMES, DECLARED PRODUCT MALFUNCTION BY SURGEON. PRODUCT MALFUNCTION REPORT DONE, PRODUCT WITH PACKAGING SENT TO SUPPLIES, CHARGE NURSE AWARE.