MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175824P0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint # (b)(4).Bubbles coming out from the tiny hole when tested the graft.Discovered before implantation, the graft was not used.They just put some saline on the tray of the graft and some bubbles coming out from the tiny hole.
Event or Problem Description
Complaint (b)(4).See mfg report 1640201-2020-00012.
Additional Manufacturer Narrative
The involved product was returned to intervascular and was inspected by our quality assurance supervisor with a quality control technician.The inspection was performed using a magnifying glass and a backlit table.It was observed that the tiny hole detected by the customer was a sewing defect not visible from the inside of the prosthesis and the light did not pass through.Therefore, the defect is classified as an acceptable defect in accordance with our list of standards for acceptation and rejection of products.The product is compliant.(67) the conducted investigation suggests that the product is not defective.

• Brand Name: HEMASHIELD
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 10257703
• Report Number: 1640201-2020-00012
• Device Sequence Number: 2485514
• Product Code: MAL
• UDI-Device Identifier: 00384401018551
• UDI-Public: 00384401018551
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K021213
• 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): 09/15/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: M00202175824P0
• Device Catalogue Number: M00202175824P0
• Device Lot Number: 19D10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1