MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD FINESSE ULTRATHIN KNITTED CARDIOVASCULAR PATCH; VASCULAR POLYESTER GRAFT

Model Number	M002000195290
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) a review of the device history records, indicated that the patch was processed and inspected according to procedures and was therefore released following acceptable quality inspections and tests, and no anomaly was found.(b)(4) a visual inspection of the returned patch was performed by the quality assurance supervisor.The product was returned in a biohazard package.The inspection revealed a collagen excess.Therefore, the product does not conform to its specification.(b)(4) the inspection confirms that the product does not conform to its specification.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.
Event or Problem Description
The hospital reported that the patch was opened on surgical field, and it appeared different to the surgeon.He saw something on the patch which looked sticky or glue like.The patch was not implanted, no consequence for the patient was reported.

• Brand Name: HEMASHIELD FINESSE ULTRATHIN KNITTED CARDIOVASCULAR PATCH
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7036306
• Report Number: 1640201-2017-00035
• Device Sequence Number: 19118810
• Product Code: DXZ
• UDI-Device Identifier: 00384401017875
• UDI-Public: 00384401017875
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K962342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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: 08/31/2021
• Device Model Number: M002000195290
• Device Catalogue Number: M002000195290
• Device Lot Number: 16J28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1