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

Model Number HGK1809

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 within product specifications.(b)(4).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.(b)(4).Please note that the device was not used in an approved indication.(b)(4).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 a cardiac surgery, the graft was used to connect the femoral artery to the cardiopulmonary bypass machine.The graft was reported to leak from the body itself, which required the use of hemostatic agent to stop the bleeding before proceeding with the operation.Patient had no complication.The product was discarded after use.

• Brand Name: HEMAGARD KNITTED GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• 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: pascal de framond ; zi athelia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208779
• MDR Report Key: 5123644
• MDR Text Key: 27328267
• Report Number: 1640201-2015-00031
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014393
• UDI-Public: 00384401014393
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/08/2015

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?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2020
• Device Model Number: HGK1809
• Device Catalogue Number: HGK1809
• Device Lot Number: 15D09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2015
• 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
• Treatment: HEPARIN
• Patient Outcome(s): Other