InjuryGAS
COR-KNOT
Received Oct 5, 2018 · Event occurred Sep 21, 2018
Report MW5080414 · MDR key 7946940
Device
Generic name
Suture, Nonabsorbable, Synthetic Polyester
Manufacturer
Lsi Solutions, Inc.Catalog number
031082
Lot number
725498
Product problems
- Misfire
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COR-KNOT MISFIRED DURING AVR. IT FIRED AND THEN CUT THE STRUCTURE BEHIND THE CLIP AND SUTURE CAME OUT. ANOTHER COR-KNOT WAS OPENED AND USED. THE 2ND DEVICE WORKED AS EXPECTED. THERE WAS NO HARM TO THE PATIENT. THE INCIDENT IS BEING REPORTED SINCE THE SURGEON, WHO HAS BEEN USING COR-KNOT FOR YEARS, HAD ANOTHER MISFIRE INCIDENT ON (B)(6) 2018 AT OUR FACILITY. BOTH INCIDENTS HAVE BEEN REPORTED TO THE MANUFACTURER, BOTH DEVICES RETURNED TO THE MANUFACTURER. BOTH ARE BEING REPORTED TO FDA.