MAUDE Adverse Event Report: LSI SOLUTIONS, INC COR-KNOT; SUTURE

Catalog Number 030800

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 05/07/2014

Event Type  malfunction  

Event Description

Cor-knot device did not deploy properly, causing the wire to break while attaching the mitral valve implant, thus requiring manual removal of the wire, suture & pledget from the implant placement area.

• Brand Name: COR-KNOT
• Type of Device: SUTURE
• Manufacturer (Section D): LSI SOLUTIONS, INC; 7796 victor-mendon rd; victor NY 14564
• MDR Report Key: 4091412
• MDR Text Key: 16183340
• Report Number: 4091412
• Device Sequence Number: 1
• Product Code: GAS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 030800
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2014
• Patient Sequence Number: 1
• Patient Age: 62 YR