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

Model Number	HGKUT0007-40
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5864359
• Report Number: 1640201-2016-00022
• Device Sequence Number: 16300125
• Product Code: DSY
• UDI-Device Identifier: 00384401014713
• UDI-Public: 00384401014713
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K983819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2016
• Initial Report FDA Received Date: 08/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1