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

Model Number	031350
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Chest Pain (1776)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Elderly male with history of coronary artery disease, recent chest pain and atrial fibrillation.Procedure: coronary artery bypass x2 and aortic valve replacement.The cor-knot malfunctioned when fired during the placement of the aortic valve.The device jammed and broke the 2.0, v-7 ethibond valve suture; the end jammed in device.The pledget had to be removed and additional suturing was put in place.No known harm to patient at this time.Manufacturer response for instrument, ligature passing and knot tying, cor-knot mini (per site reporter), will obtain when available.

• Brand Name: COR-KNOT MINI
• 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: 18353532
• Report Number: 18353532
• Device Sequence Number: 6775215
• Product Code: HCF
• UDI-Device Identifier: 00850200006292
• UDI-Public: (01)00850200006292(17)260731(11)230825(10)2114057
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/08/2023
• Report Date (Section F): 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 031350
• Device Catalogue Number: 031350
• Device Lot Number: 2114057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male
• Patient Weight: 80 KG
• Date Report Sent to FDA: 12/08/2023