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

Model Number	IGK1407 - INTERGARD KNITTED BIFURCATED
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional 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 (b)(6) 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 or Problem 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 is ok according to the complainant.

• Brand Name: INTERGARD KNITTED
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• MDR Report Key: 11004292
• Report Number: 1640201-2020-00025
• Device Sequence Number: 3617897
• Product Code: DSY
• UDI-Device Identifier: 00384401000471
• UDI-Public: 00384401000471
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K964625
• 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): 12/14/2020

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: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: IGK1407 - INTERGARD KNITTED BIFURCATED
• Device Catalogue Number: IGK1407
• Device Lot Number: 20J24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1