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

Model Number	031350
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: cor - knot mini device malfunction, device is cutting the suture prematurely.Intraoperatively, said device cut the suture before having the suture secured with interlocking attachment from said device.Having that into consideration, that is a risk for the suture to be loose and movable, further causing peri valvular leak or may result for the implanted valve to be rendered ineffective and cause patient harm.The said device has ref# 031350.Device was taken out of the field as soon as malfunctioning was noticed, device was put in its original packaging and placed in a biohazardous bag.

• 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: 23072368
• Report Number: 23072368
• Device Sequence Number: 9719824
• Product Code: HCF
• UDI-Device Identifier: 00850200006292
• UDI-Public: (01)00850200006292
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 09/15/2025
• Report Date (Section F): 09/15/2025

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: 031350
• Device Catalogue Number: 031350
• Device Lot Number: 8631473
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2025
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Date Report Sent to FDA: 09/15/2025