MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC; VASCULAR POLYESTER GRAFT

Model Number M002000195090

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) a review of the complaint device history records, indicated that the graft was processed and inspected according to procedures and was therefore released following acceptable quality inspections and tests.These tests include a 100 % visual inspection of the patch.(b)(4) the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

The hospital reported that during preparation to use the patch, the involved product package was sticky.A replacement product was used to complete the procedure.No consequence for the patient was reported.

Manufacturer Narrative

A visual inspection of the returned patch was performed by the quality assurance supervisor.The inspection revealed that the product was returned with its packaging open and seemed to have been soaked in a liquid due to its dry and rigid aspect.The initial report mentioned that the "fabric package was sticky" but it has not been confirmed during the evaluation.Therefore, the patch, as it was received, does not conform to its specification.No conclusion can be drawn.The conducted investigation would tend to indicate that the device was meeting its specification at the time of manufacturing.No further information from the hospital could be obtained regarding the manipulation and preparation of the patch.

• Brand Name: HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
• 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 athelia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208464
• MDR Report Key: 6680643
• MDR Text Key: 79150394
• Report Number: 1640201-2017-00021
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00384401017905
• UDI-Public: 00384401017905
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K955349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2021
• Device Model Number: M002000195090
• Device Catalogue Number: M002000195090
• Device Lot Number: 16K26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1