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

Model Number HEWAA2410080810/1

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 20m24.Based on the picture provided by the customer, the product damage was confirmed.It appears to be caused by a bad handling of the product box, which may have occurred during storage/transport.The conducted investigation confirmed that the product was defective when received by the customer, due to an handling issue of the product box, which may have occurred during storage/transport.Therefore, an internal non-conformity report has been initiated in order to investigate the root cause and to take appropriate corrective 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

When the customer (distributor) checked the received goods, he found a product box damaged.According to the customer, the shipping box outside was intact.Complaint # (b)(4).

• Brand Name: INTERGARD WOVEN AORTIC ARCH
• 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 ; 442084646
• MDR Report Key: 11715363
• MDR Text Key: 251711719
• Report Number: 1640201-2021-00009
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401010739
• UDI-Public: 01003844010107391120122417251130
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2021

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 Model Number: HEWAA2410080810/1
• Device Catalogue Number: HEWAA2410080810/1
• Device Lot Number: 20M24
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1