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

Model Number	HGK0007-40
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date was set on (b)(6) 2021 as it was the day the product damage was detected by the customer.However, the shipment was in transit from (b)(6) 2021, therefore the event may have occurred between these two dates.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.The involved product was returned to intervascular and was inspected by our quality assurance (qa) manager for an evaluation of the damage extent.His observations are as follows: "we can observe, on the right side of the outer box, a small bulge which is due to the absorption of a liquid.Upon opening the box and taking out the primary packaging of this product we can see that it is the pet part of the shell that is in contact with the identified area of the bulge.The outer lid does not have any rings or curls on the surface that would suggest that liquid has penetrated the box.This could only have occurred when the product was shipped to the end customer because the product was never stored at the end customer's location (problem detected upon delivery to them) and it seems unlikely that following a storage problem at our storage location [subcontracted storage], the product was shipped by our storage subcontractor like this." the most likely cause of this event is an inappropriate handling of the parcel during transport.An internal non-conformity report has been initiated in order to take appropriate actions if necessary.Please note the presence of the following mention on the instructions for use: "contents sterile unless package is opened or damaged.Do not use if sterile barrier is damaged.If damage is found, call your local distributor or getinge representative.".
Event or Problem Description
At delivery receipt, the shipping box was wet in one place.It was reported that the box of the prosthesis was also soaked through.

• 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 13705 ; FR 13705
• MDR Report Key: 11494131
• Report Number: 1640201-2021-00007
• Device Sequence Number: 19550730
• Product Code: DSY
• UDI-Device Identifier: 00384401014102
• UDI-Public: 00384401014102
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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 Expiration Date: 10/31/2025
• Device Model Number: HGK0007-40
• Device Catalogue Number: HGK0007-40
• Device Lot Number: 20L26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/16/2021
• Patient Sequence Number: 1