MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number IGW0030-15 - INTERGARD WOVEN STRAIGHT

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

The event date was set on (b)(6) 2020 as it was the day the damage was reported to us.However, the shipment was in transit from nov 2, 2020, therefore the event may have occurred between these two dates.The device was not made available to the manufacturer.The distributor preferred to keep the goods.According to the complainant, transport problem identified.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.However, another product was damaged in the same delivery (complaint # (b)(4)).A mdr is submitted in parallel for this other product.The most likely cause of this event is an inappropriate handling of the parcel during transport.An internal non-conformity report has been initiated in order to take appropriate actions if necessary.Please note the presence of the following mention on the instructions for use: "contents sterile unless package is opened or damaged.Do not use if sterile barrier is damaged.If damage is found, call your local distributor or getinge representative.".

Event Description

Complaint #(b)(4).The forwarder had a bad handle of the box during the transport to the distributor.The product box is damaged but the product itself is ok according to the complainant.

• Brand Name: INTERGARD WOVEN
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: francoise gauduchon ; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• MDR Report Key: 11004274
• MDR Text Key: 250085079
• Report Number: 1640201-2020-00026
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000259
• UDI-Public: 00384401000259
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGW0030-15 - INTERGARD WOVEN STRAIGHT
• Device Catalogue Number: IGW0030-15
• Device Lot Number: 20J10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2020
• 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