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

Model Number M002000195290

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2017

Event Type  malfunction  

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 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
• 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 ; z.i. athélia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7036306
• MDR Text Key: 93080404
• Report Number: 1640201-2017-00035
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00384401017875
• UDI-Public: 00384401017875
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• 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