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 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

On date of event, the event date was set on (b)(6) 2021, as is was the day the product damaged was received by the customer.The damage to the products occurred between the day of shipment and the day of receipt, which is between (b)(6) 2021.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21k07.As the defects appear obvious on the pictures provided, a visual inspection based on pictures received was performed by our qa supervisor.His conclusion is as follows : " based on the pictures, i confirm that the product in the state is not in conformity.A damage during transportation seems to be the most probable root cause." the most probable root cause of this event is an improper handling of the package during transport.An internal non-conformity report has been initiated in order to take appropriate action.

Event Description

Article hewaa2410080810 / 1 (b)(4).Packaging arrived damaged, customer wants to return goods.(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: philip gaillard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 12880458
• MDR Text Key: 285487867
• Report Number: 1640201-2021-00036
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401010739
• UDI-Public: (01)00384401010739
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEWAA2410080810/1
• Device Catalogue Number: HEWAA2410080810/1
• Device Lot Number: 21K07
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1