MAUDE Adverse Event Report: INTERVASCULAR SAS HEMACAROTID PATCH; VASCULAR GRAFT PROSTHESIS

Model Number HEK08/75CPUT(1)

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Blood Loss (2597)

Event Date 06/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the complaint device history records, including collagen coating records, indicated that the patch 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.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 surgery performed on (b)(6) 2015, 30 minutes after a thromboendarterectomy intervention of the left carotid with placement of the patch, the wound had to be reopened because of multiple sources of bleeding.This required the use of hemostatic agents, and the surgery was prolonged by an unknown amount of time.The patch remained implanted.

• Brand Name: HEMACAROTID PATCH
• 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: laure fraysse ; zi athélia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208464
• MDR Report Key: 5418534
• MDR Text Key: 37714692
• Report Number: 1640201-2016-00003
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401001478
• UDI-Public: 00384401001478
• 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,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2020
• Device Model Number: HEK08/75CPUT(1)
• Device Catalogue Number: HEK08/75CPUT(1)
• Device Lot Number: 15B05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR