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

Model Number	HGK0008-70
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/13/2016
Type of Reportable Event	Serious Injury
Additional 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 testing performed would tend to indicate that the device was not defective.Please note that, as per the product instructions for use, the graft was not used in an approved indication.
Event or Problem Description
During a femoro-femoral bypass procedure performed on (b)(6) 2016, the patient was on extracorporeal membrane oxygenation with an initial cannulation at the femoral artery level and was reported to be very sick.The surgeon wanted to move the cannulation to the axillary artery and he used for that the involved hemagard graft.The graft was reported to leak a lot and the bleeding could not be contained.So the graft could not be left in place and the cannulation was moved to its initial localisation.The procedure was then completed and the graft was discarded.No adverse outcome for the patient was reported after the surgery.It was afterwards reported that the patient deceased at a later date due to other causes unrelated to this incident.

• Brand Name: HEMAGARD KNITTED STRAIGHT GRAFT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5842775
• Report Number: 1640201-2016-00020
• Device Sequence Number: 597757
• Product Code: DSY
• UDI-Device Identifier: 00384401014157
• UDI-Public: 00384401014157
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2016

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
• Operator of Device: No Information
• Device Expiration Date: 03/31/2020
• Device Model Number: HGK0008-70
• Device Catalogue Number: HGK0008-70
• Device Lot Number: 15D16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2016
• Initial Report FDA Received Date: 08/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other