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

Model Number HGKUT0007-40

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.(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).No conclusion can be drawn.However, all available information and testing performed would tend to indicate that the device was not defective.(b)(4).Please note that, as per the product instructions for use, the flushing with saline solution before implantation is not listed on the label directions.

Event Description

During the leak test performed on (b)(6) 2016 prior to the surgical procedure with a saline solution, the involved graft appeared to be permeable.So the graft was not used for implantation and was immediately changed with another one.The involved device was not kept for evaluation.

• Brand Name: HEMAGARD KNITTED ULTRATHIN STRAIGHT GRAFT
• 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: 5864359
• MDR Text Key: 52722345
• Report Number: 1640201-2016-00022
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014713
• UDI-Public: 00384401014713
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K983819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/18/2016

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: No Information
• Device Expiration Date: 02/29/2020
• Device Model Number: HGKUT0007-40
• Device Catalogue Number: HGKUT0007-40
• Device Lot Number: 15C19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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