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

Model Number	HGK0008-40
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We do not know yet if the device is available for investigation.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.We don't know yet if the device is available.
Event or Problem Description
The packaging has arrived damaged and moist at the customer, so that the sterility of the product is no longer guaranteed.
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 product arrived in its box but damaged.The external and internal lids were not open.There is a match between the product, the labelling of the box and the patient set.The outer lid does not have any haloes on the surface that would suggest that a liquid may have passed through the packaging box." (4308) the most likely cause of this event is an inappropriate transport of the device.In conclusion, the product does not comply with the specifications due to damaged packaging.Based on the defect present on the product box, it is assumed that this is an isolated event due to a shock during transportation.Corrected data: d10.The product was initially reported as not available for evaluation.It has been changed to available for evaluation.

• Brand Name: HEMAGARD KNITTED
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9209527
• Report Number: 1640201-2019-00080
• Device Sequence Number: 305355
• Product Code: DSY
• UDI-Device Identifier: 00384401014140
• UDI-Public: 00384401014140
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K964625
• 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): 12/16/2019

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: No Information
• Device Expiration Date: 07/31/2024
• Device Model Number: HGK0008-40
• Device Catalogue Number: HGK0008-40
• Device Lot Number: 19H29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1