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

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No review of the complaint device history records could have been performed since no product identifier has been obtained at the date of this report.No device evaluation could have been performed since the involved product is not available for investigation.No conclusion can be drawn.

Event Description

The hospital reported that the patch was discolored and was not willing to use it.No patient was involved in this case.

Manufacturer Narrative

((b)(4)) a visual inspection was performed on the two returned products.The patches were returned sealed in their original packaging, as they were not used during surgery.They were opened for inspection, no abnormal discoloration was observed on the patches themselves.However, the presence of glycerol (one of the raw materials) on the patch creates an interface between the patch and the blister which is responsible of this "discolored" visual effect as reported.This is a visual effect only with no impact on the product itself.No failure was detected.((b)(4)) therefore, no failure was detected.The products conform to the specification.Please note that, at the time of the initial report, the worst case was taken into account as no product identification nor product return were available.Upon receipt of the products, it appears that there was no failure.Therefore, the initial report should not has been submitted.

Event Description

Two products were finally returned as part of this complaint : hemacarotid patch ultrathin - hek10/75cput (1) - serial number: (b)(4) - lot: 16m22 - (b)(4) - device manufacture date: 12/22/2016 - expiration date: 11/30/2021 and hemacarotid patch ultrathin - hek10/75cput (1) - serial number: (b)(4) - lot: 16m29 - (b)(4) - device manufacture date: 12/29/2016 - expiration date: 11/30/2021.

• Brand Name: HEMACAROTID 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 ; zi athelia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208464
• MDR Report Key: 6510979
• MDR Text Key: 73393809
• Report Number: 1640201-2017-00011
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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