MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN; VASCULAR POLYESTER GRAFT

Model Number IGW0028-15

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

The involved product was returned to intervascular and was inspected by our quality assurance (qa) manager for an evaluation of the damage extent.His observations are as follows: the external shipping box was delivered damaged to the client (presence of a hole).The product box is damaged as well (hole) but the tamper-evident labels are intact.There is a match between the labelling of the box and the external tyvek.The seals seem to have integrity.The product contained in the shell corresponds to the labelling.In conclusion, the product does not comply with the specifications due to a damaged packaging.Based on the hole present in the outer shipping box and the product box, it is assumed that the event occurred during transportation.The most likely cause of this event is an inappropriate handling of the shipment during transport.The situation was reported to our logistics subcontractor.

Event Description

A transportation problem occurred.Upon delivery to the customer, a hole was identified in the outer packaging and in one of the product boxes.

• Brand Name: INTERGARD WOVEN
• Type of Device: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• Manufacturer Contact: laure fraysse ; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8403407
• MDR Text Key: 139341897
• Report Number: 1640201-2019-00018
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000235
• UDI-Public: 00384401000235
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K984294
• 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: 03/08/2019

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
• Device Expiration Date: 10/31/2023
• Device Model Number: IGW0028-15
• Device Catalogue Number: IGW0028-15
• Device Lot Number: 18L08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• 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