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

Model Number HEWROOT0030

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2017

Event Type  malfunction  

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 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.

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
• 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
• MDR Report Key: 6896792
• MDR Text Key: 88252042
• Report Number: 1640201-2017-00031
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401013914
• UDI-Public: 00384401013914
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K103347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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