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

Model Number	M002000195090
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6680643
• Report Number: 1640201-2017-00021
• Device Sequence Number: 18866804
• Product Code: DXZ
• UDI-Device Identifier: 00384401017905
• UDI-Public: 00384401017905
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K955349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2017

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: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1