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

Model Number IGW0008-30

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 12/31/2021

Event Type  malfunction  

Manufacturer Narrative

The event date was set on (b)(6) 2021, as is was the day the product damaged was detected 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 21l11.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

With (b)(4), the customer received an article in which the outer packaging was slightly damaged.To be on the safe side, the item is returned back and the customer will receive new goods.It is consignment goods.Complaint # (b)(4).

Event Description

Mfg report#: 1640201-2022-00002.Complaint#: (b)(4).

Manufacturer Narrative

(10/3236) 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 internal list of standards for acceptation and rejection for packaging due to a damaged packaging.(4308) the conclusions of the inspection are that the product is not compliant due to a damaged packaging and the exact root cause is unclear but probably related to inappropriate handling by logistic service providers.An internal non-conformity report has been initiated in order to take appropriate actions if necessary.

• Brand Name: INTERGARD WOVEN STRAIGHT
• 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: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 13357746
• MDR Text Key: 295609050
• Report Number: 1640201-2022-00002
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000037
• UDI-Public: (01)00384401000037
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K970843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGW0008-30
• Device Catalogue Number: IGW0008-30
• Device Lot Number: 21L11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: N/A.