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

Model Number	IGW0026-15
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The external packaging of the product was torn/ dented.The product was not implanted, therefore no patient was harmed.Complaint # (b)(4).
Additional Manufacturer Narrative
The event date was set on (b)(6) 2022, as is was the day the product damaged was detected by the customer.The damage to the product occurred between the day of shipment and the day of receipt, which is between 24 january 2022 and 25 january 2022.The involved product was returned to intervascular and was inspected by the quality assurance (qa) manager for an evaluation of the damage extent.In conclusion, the product does not comply with the specifications due to a damaged packaging.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21g22.The most probable root cause of this event is an improper handling of the package during transport by the logistic subcontractor.An internal non-conformity report has been initiated in order to take appropriate action.

• Brand Name: INTERGARD WOVEN STRAIGHT
• 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
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 13547620
• Report Number: 1640201-2022-00005
• Device Sequence Number: 20083016
• Product Code: DSY
• UDI-Device Identifier: 00384401000211
• UDI-Public: (01)00384401000211
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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: 06/30/2026
• Device Model Number: IGW0026-15
• Device Catalogue Number: IGW0026-15
• Device Lot Number: 21G22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown