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

Model Number	031350
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was diagnosed to have severe aortic valve stenosis.Cardiac catheterization was also then performed which revealed nonobstructive coronary artery disease.Patient is now referred for possible aortic valve intervention.Patient was in the surgical suite for an aortic valve replacement.A timeout was completed, verifying correct patient, procedure site and positioning.General anesthesia was induced, and central venous access was obtained.An arterial line and foley catheter were placed, a swan-ganz catheter was positioned, and a tee probe was placed.The patient was then positioned, prepared and draped in a sterile manner.A cor-knot mini combo device was used to secure the sutures.Per rn report: the blades were dulling before 6 cuts were made and they were not cutting the sutures.The device was replaced with another similar one and the procedure was concluded with no further incident.No patient harm.Manufacturer response for instrument, ligature passing and knot tying, cor-knot mini® (per site reporter).Device and info given to med field representative.

• 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: 21605440
• Report Number: 21605440
• Device Sequence Number: 9217733
• Product Code: HCF
• UDI-Device Identifier: 00850200006292
• UDI-Public: (01)00850200006292(17)270630(10040730(10)5128093
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/20/2025
• Report Date (Section F): 02/20/2025

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: 5128093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Date Report Sent to FDA: 02/20/2025