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

Model Number	M00202175826P0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of historical data indicated that no other similar complaints was reported for the same sterilization lot.The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.The involved product was returned to intervascular and was visually inspected by our quality assurance (qa) supervisor.The conclusion is as follows: " i confirm that there are yellow blots on the product which are defect related to excesses of collagen : cosmetic defect without impact on the product use." "the defect is non acceptable according to the acceptance criteria." the outcome of the investigation would tend to indicate that the issue is related to a presence of collagen excesses which should have been rejected during the 100% visual inspection.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.
Event or Problem Description
(b)(4).When the customer opened the package, he found yellow blots on the surface of the graft.

• Brand Name: HEMASHIELD PLATINIUM WOVEN DOUBLE VELOUR VASCULAR GRAFT
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9660850
• Report Number: 1640201-2020-00002
• Device Sequence Number: 16974073
• Product Code: MAL
• UDI-Device Identifier: 00384401018568
• UDI-Public: 00384401018568
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 02/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: M00202175826P0
• Device Catalogue Number: M00202175826P0
• Device Lot Number: 18H01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2020
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1