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

Model Number IGK1407

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 10/25/2021

Event Type  malfunction  

Event Description

It was reported that, during the review of imported products, a box was found with the secondary packaging broken.(b)(4).

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 Description

See mfg report(s) 1640201-2021-00038.Complaint #(b)(4).

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
• 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: 12923797
• MDR Text Key: 283678797
• Report Number: 1640201-2021-00038
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000471
• UDI-Public: (01)00384401000471
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K964625
• 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,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/28/2021
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose