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

Model Number	030800
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Valvular Insufficiency/ Regurgitation (4449)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor was performing a minimally invasive mitral valve repair.Doctor uses a single use device called a "cor-knot" to tie valve sutures.These sew in the prosthetic heart valve into the patient.Twice, the cor-knot device cut a suture.Dr.Had to retrieve the suture¿s pledgets that had fallen into the patient¿s left atrium.The valve was already in place and nearly all of the sutures were tied.As a result of the broken sutures, the valve "leaked" and to correct that, the surgeon had to re-do those sutures.Another cor-knot device was opened, and it too, broke a suture.Dr.Told the surgical team, and the anesthesiologist performing the transesophageal echocardiogram prior to coming off cardiopulmonary bypass, that if the patient's left ventricle distended due to any perivalvular leak, then he would have to remove the valve and do the replacement all over again.There were a total of three sutures that were broken between the use of the device(s).Both devices had the same lot number.

• Brand Name: COR-KNOT
• 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: 17820639
• Report Number: 17820639
• Device Sequence Number: 6138145
• Product Code: HCF
• UDI-Device Identifier: 00850200006100
• UDI-Public: (01)00850200006100
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/20/2023
• Report Date (Section F): 09/20/2023

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: 1231004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: White
• Date Report Sent to FDA: 09/20/2023