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

Model Number HGK1608

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

A review of the complaint 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 within product specifications.One retention sample coated on 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.No conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.

Event Description

During an aorto bi-femoral intervention performed on (b)(6) 2016 it was reported that a blood leaking occurred through the graft.Hemostatic agent was used and protamine was administrated as antidotum on heparinisation of the patient in order to stop the bleeding.The involved graft remained implanted.No adverse consequence for the patient was reported.

Manufacturer Narrative

(b)(4).

• Brand Name: HEMAGARD KNITTED
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer Contact: laure fraysse ; zi athélia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208464
• MDR Report Key: 6203821
• MDR Text Key: 63259457
• Report Number: 1640201-2016-00038
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014027
• UDI-Public: 00384401014027
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2019
• Device Model Number: HGK1608
• Device Catalogue Number: HGK1608
• Device Lot Number: 14G03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention