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

Model Number	HGK0006-40
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/08/2015
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 (b)(4).The test result indicated a value well within product specifications.(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 or Problem Description
During a surgery performed on (b)(6) 2015, the graft was reported to bleed for more than 10 minutes.No additionnal information could be obtained at the date of this report.
Additional Manufacturer Narrative
The complaint device has been sent to an outside laboratory for macroscopic and scanning electron microscopy (sem) evaluation.The sem analysis showed no significant textile abnormality such as tear, hole, filament rupture or sectioning, loss of the textile cohesion, neither macroscopically nor ultrastructurally.The presence of collagen coating was confirmed.No conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.

• 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: 5343213
• Report Number: 1640201-2015-00047
• Device Sequence Number: 260415
• Product Code: DSY
• UDI-Device Identifier: 00384401014058
• UDI-Public: 00384401014058
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Followup
• Report Date (Section B): 12/08/2015

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/31/2018
• Device Model Number: HGK0006-40
• Device Catalogue Number: HGK0006-40
• Device Lot Number: 13J26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2016
• Supplement Report FDA Received Date: 04/19/2016
• 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