MAUDE Adverse Event Report: INTERVASCULAR HEMAGARD KNITTED GRAFT; VASCULAR GRAFT PROSTHESIS

Model Number HGK0008-20

Device Problems Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 11/09/2014

Event Type  malfunction  

Event Description

During an ascending aorta aneurysm repair performed on (b)(6) 2014, the involved graft was used as a cannulation for blood transmission.The graft was used as a cannulation for blood transmission.The graft was reported to leak during the procedure.The graft clotted after a wait and was not replaced.No pt injury was reported.

Manufacturer Narrative

A review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing records of products coated on the same day and under the same conditions as the complaint device indicated values will within product specifications.One retention sample coated in the same period and under the same conditions as the complaint device underwent water permeability testing at 120mmhg as per iso 7198.The test result indicated a value well within product specifications.Please note that the device was not used in an approved indication.No conclusion can be drawn.However, all available info and the product testing performed would tend to indicate that the device was not defective.

• Brand Name: HEMAGARD KNITTED GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR; zi athelia 1; la iotat cedex 1360 5; FR 13605
• Manufacturer Contact: pascal de framond ; zi athelia 1; la ciotat cedex 13605 ; FR 13605 ; 42084646
• MDR Report Key: 4340538
• MDR Text Key: 18031049
• Report Number: 1640201-2014-00035
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: HGK0008-20
• Device Catalogue Number: HGK0008-20
• Device Lot Number: 14F19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1