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

Model Number	IGW0008-30
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem Description
Mfg report#: 1640201-2022-00002.Complaint#: (b)(4).
Additional 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
• 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: 13357746
• Report Number: 1640201-2022-00002
• Device Sequence Number: 1778902
• Product Code: DSY
• UDI-Device Identifier: 00384401000037
• UDI-Public: (01)00384401000037
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K970843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown