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

Model Number IGW0026-15

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 01/25/2022

Event Type  malfunction  

Event Description

The external packaging of the product was torn/ dented.The product was not implanted, therefore no patient was harmed.Complaint # (b)(4).

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
• 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: 13547620
• MDR Text Key: 296376246
• Report Number: 1640201-2022-00005
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401000211
• UDI-Public: (01)00384401000211
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K984294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1