MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRICS; VASCULAR POLYESTER GRAFT

Model Number	M002000195140
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the serial number of the concerned patch is not available, only the lot number was confirmed.
Event or Problem Description
During a carotid endarterectomy, a first patch was implanted but looked "more yellow" and it felt "fuzzier and thicker" than previous used patches (see manufacturer report 1640201-2018-00021 for this first involved device).The surgeon opened a second box (sterile pack remained closed) with a different lot number.This second patch looked the same and is the subject of the present report.
Additional Manufacturer Narrative
(b)(4).The returned device was visually inspected by our qa supervisor.No anomaly was found, the patch complies with our product specifications.(b)(4) the conducted investigation indicates that the product was not defective.

• Brand Name: HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRICS
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 8024893
• Report Number: 1640201-2018-00022
• Device Sequence Number: 16489470
• Product Code: DXZ
• UDI-Device Identifier: 00384401017899
• UDI-Public: 00384401017899
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K955349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

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: 11/30/2022
• Device Model Number: M002000195140
• Device Catalogue Number: M002000195140
• Device Lot Number: 17M13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1