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

Model Number	HEWROOT0028
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On date of event, the event date was set on (b)(6) 2021 as it was the day the product damage was communicated to us by the customer.However, the shipment was in transit from (b)(6) 2021, therefore the event may have occurred between these two dates.The involved device was returned to intervascular for examination.The examination is pending.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
This is a case of a product damaged during transportation.The carrier (dhl) put a box with water (who had leeches inside) in the same transportation of our product.This box broke open and all the liquid came on the cardioroot product.Therefore the product was damaged when it arrived at the end customer.The product has then been returned to the manufacturer.Complaint #(b)(4).
Additional Manufacturer Narrative
Block b3: the event date was set on (b)(6) 2021.Indeed, it was confirmed by additional information that the product was first refused by the customer upon receipt on (b)(6) 2021 because it was wet.Then the product was repacked by the carrier and was presented again to the customer on (b)(6) 2021 and the customer issued a complaint.The event may have occurred between (b)(6) 2021 (shipping date) and (b)(6) 2021 (1st receipt date).(10/3236) the returned device was visually inspected by the qa supervisor.Below are the main observations: the product arrived packed in a dhl shipping box.Three small swellings were observed on internal and external sides of the product box.The area of the outer cover of the shell which was in contact with the identified area does not have any streaks/halos or curls on the surface.The conclusion of the inspection is that this could only have occurred when the product was shipped to the final customer because the product was never stored at the final customer premises (problem detected on receipt by them) and it seems unlikely that following a storage problem at our logistical partner, the product has been sent by our logistical partner like this.(4308) the most likely cause of this event is an inappropriate transport of the device: a damage occurred during transport due to a special circumstance of this shipment and the carrier repacked the product.An internal non-conformity report has been initiated in order to take appropriate action.
Event or Problem Description
See initial mfr report 1640201-2021-00010.Complaint # (b)(4).

• Brand Name: CARDIOROOT
• 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: 11764682
• Report Number: 1640201-2021-00010
• Device Sequence Number: 16914282
• Product Code: DSY
• UDI-Device Identifier: 00384401013907
• UDI-Public: 01003844010139071121012817251231
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K103347
• 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,Followup
• Report Date (Section B): 05/29/2021

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: 12/31/2025
• Device Model Number: HEWROOT0028
• Device Catalogue Number: HEWROOT0028
• Device Lot Number: 21A28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/29/2021
• Patient Sequence Number: 1