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

Model Number	IGW0028-15
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8403407
• Report Number: 1640201-2019-00018
• Device Sequence Number: 420838
• Product Code: DSY
• UDI-Device Identifier: 00384401000235
• UDI-Public: 00384401000235
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1