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

Model Number HGK0008-20

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 10/28/2014

Event Type  malfunction  

Event Description

During an aortic surgery performed on (b)(6) 2014, the graft was reported to leak.No patient 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 well with product specifications.One retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 120 mmhg as per iso 7198.The test result indicated a value well within product specifications.No conclusion can be drawn.However, all available information 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, SAS; zi athelia 1; laciotat, cedex 1360 5; FR 13605
• Manufacturer Contact: pascal de framond ; z athelia 1; laciotat, cedex 13605 ; FR 13605 ; 42084646
• MDR Report Key: 4307353
• MDR Text Key: 5213314
• Report Number: 1640201-2014-00033
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: HGK0008-20
• Device Catalogue Number: HGK0008-20
• Device Lot Number: 14G10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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