MAUDE Adverse Event Report:; NONE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Reference importer # (b)(4).

Manufacturer Narrative

During cardiac surgery, reportedly an aortic valve replacement, involving a cor-knot mis kit, it was stated that a cor-knot mis device "would not cut after crimping." they reported no patient harm.The device in question was returned to our manufacturing facility, decontaminated and thoroughly evaluated by a senior engineer per established protocol.The suture cutting blade travel was noted to have less than 100% of full travel and the stainless steel shaft tube was found to be partially dislodged from the plastic handles.Functional testing of fasteners crimped by the returned device demonstrated an average holding strength of 2.82 kgf (98% of usp) with a minimum value of 2.60 kgf (90%).Extrapolation using the device's initial holding force indicates that the holding force of any knots used in the actual surgery would be above (105%) the usp standard.This shaft tube finding is most consistent with improper alignment of the tube's handle gripping features during manufacturing.While this device malfunction represents an inconvenience to the surgical staff, titanium fastener suture holding forces were not significantly compromised.This event caused no patient harm during the operation and represents very little risk of any subsequent related problems.The warning section of this product's technology guide (instructions for use) instructs customers to not use "damaged" cor-knot product.All representatives in the field involved with hospital staff training provide in service and intraoperative instructions concerning the immediate removal from use of any cor-knot device displaying suboptimal performance.Hospital staff are also instructed to return any device in question to our manufacturing facility.Corporate senior management, along with regulatory, quality and engineering leadership are committed to monitoring any observations of cor-knot product performance concerns, specifically including suboptimal suture cutting and potential knot security, as part of an ongoing in depth analysis of related issues.Device component and manufacturing process have subsequently been improved.Product literature enhancements have also already been implemented.

• Type of Device: NONE
• Manufacturer Contact: kevin bentley ; 7796 victor-mendon rd.; victor, NY 14564 ; 5858696669
• MDR Report Key: 3783815
• MDR Text Key: 4441571
• Report Number: 1320468-2014-00010
• Device Sequence Number: 1
• Product Code: HCF
• Combination Product (y/n): N
• PMA/PMN Number: K100593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1