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

Model Number	HGK1407
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/26/2016
Type of Reportable Event	Malfunction
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.((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 (b)(4).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 or Problem Description
It was reported that during a vascular surgery performed on (b)(6) 2016, the graft was weeping blood.After the initial period of leakage, the graft appeared to function normally.This resulted in a greater than normal blood loss.The outcome was reported to be fine, the graft remained implanted.

• Brand Name: HEMAGARD KNITTED GRAFT
• Common Device Name: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5453900
• Report Number: 1640201-2016-00005
• Device Sequence Number: 13528687
• Product Code: DSY
• UDI-Device Identifier: 00384401014386
• UDI-Public: 00384401014386
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2016

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: HGK1407
• Device Catalogue Number: HGK1407
• Device Lot Number: 15D23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2016
• Initial Report FDA Received Date: 02/23/2016
• 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