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

Model Number	IGK1407
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the review of imported products, a box was found with the secondary packaging broken.(b)(4).
Additional 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.It was reported that the product is available for investigation, it should be returned to intervascular for examination.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 20l19.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
See mfg report(s) 1640201-2021-00038.Complaint #(b)(4).
Additional Manufacturer Narrative
(10/3236): the involved product was returned to intervascular and was inspected by the quality assurance (qa) supervisor for an evaluation of the damage extent.His observations are as follows: "the outer box of the product is torn just next to the closing tab on 3 cm only on one side of the box.The tamper-evident labels are not cut, so the box has not been opened.There is a match between the product, the labeling of the box and the patient set.This may have occurred during shipment/transport of the product to the end customer or during preparation of the package at gxo for shipment to the end customer because the product was never stored at the end customer's location (problem detected upon delivery to them)." in conclusion, the product does not comply with the specifications due to a damaged packaging.(4308): 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 KNITTED BIFURCATED
• 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: philip gaillard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 12923797
• Report Number: 1640201-2021-00038
• Device Sequence Number: 17369934
• Product Code: DSY
• UDI-Device Identifier: 00384401000471
• UDI-Public: (01)00384401000471
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2022

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: 10/31/2025
• Device Model Number: IGK1407
• Device Catalogue Number: IGK1407
• Device Lot Number: 20L19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose