MAUDE Adverse Event Report: LSI SOLUTIONS, INC. COR-KNOT MIS DEVICE KIT; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Model Number	030800
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an emergent surgery procedure of a critical patient with large perciardial effusion, a 21 mm edwards bovine pericardial valve infra annular sutures were placed circumferentially passed through the sewing ring of the valve and the valve was lowered into position and then the sutures were tied using the core knot device.Unfortunately, there were 3 or 4 misfires of the cor-knot and the sutures could not be replaced and therefore was elected to take that valve out.We replaced the sutures, reposition a new 21 mm valve and then hand tied the sutures.Once the valve was seated correctly sutures were tied appeared to be in good position and then the aortotomy was closed in a 2-layer technique as usual.The patient left surgery and was transported to the intensive care unit in critical condition intubated.The cor-knot device that failed was saved and given to the sales representative to return to the manufacturer for inspection.

• Brand Name: COR-KNOT MIS DEVICE KIT
• Common Device Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): LSI SOLUTIONS, INC.; 7796 victor-mendon rd.; victor NY 14564
• MDR Report Key: 16991508
• Report Number: 16991508
• Device Sequence Number: 17902288
• Product Code: HCF
• UDI-Device Identifier: 00850200006100
• UDI-Public: 00850200006100
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2023
• Report Date (Section F): 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 030800
• Device Catalogue Number: 030800
• Device Lot Number: 856495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 05/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Weight: 75 KG
• Date Report Sent to FDA: 05/17/2023