MAUDE Adverse Event Report: INTERVASCULAR SAS CARDIOROOT; VASCULAR POLYESTER GRAFT

Model Number	HEWROOT0030
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the product was returned for evaluation.A mismatch between the graft itself (axillo bifemoral knitted graft, radially supported, diameter 8 mm, length 60 cm body/30 cm branch) and its labeling (cardioroot graft, diameter 30 mm) was confirmed.A non conforming report has been initiated.The most probable identified root cause is a product mix-up occuring during a manufacturing step.
Event or Problem Description
It was reported that before a surgery, while opening the packaging, the device found in the box was significantly different than the labelled one.The device has not been used has been returned for evaluation.
Additional Manufacturer Narrative
The conducted investigation concludes that the root cause is a product mix-up between two products.The inversed device is located in mexico and will be returned as part of a recall.No other product was involved in the reported event.

• Brand Name: CARDIOROOT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6896792
• Report Number: 1640201-2017-00031
• Device Sequence Number: 13612293
• Product Code: DSY
• UDI-Device Identifier: 00384401013914
• UDI-Public: 00384401013914
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 02/28/2022
• Device Model Number: HEWROOT0030
• Device Catalogue Number: HEWROOT0030
• Device Lot Number: 17C02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1