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 Consequences Or Impact To Patient (2199)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a carotid endarterectomy, upon opening of the patch, it looked "more yellow" and it felt "fuzzier and thicker" than previous used patches.This first patch remained implanted.No consequences or impact to patient.The surgeon opened another box (sterile pack remained closed) with a different lot number but it looked the same.This second patch is available for investigation (see manufacturer report 1640201-2018-00022 for this second involved device).
Additional Manufacturer Narrative
(4102/4103/213) a retention sample coated on the same day and under same conditions as the involved device and the returned device from report 1640201-2018-00022 that looked the same as the involved device according to the surgeon, were simultaneously visually inspected by our qa supervisor.No anomaly was found in either patch, they both comply with our product specifications.(67) the conducted investigation would tend to indicate 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: 8024891
• Report Number: 1640201-2018-00021
• Device Sequence Number: 19242619
• 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
• Device Implanted Year: 2018
• 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: 10/31/2022
• Device Model Number: M002000195140
• Device Catalogue Number: M002000195140
• Device Lot Number: 17L22
• Was Device Available for Evaluation?: No
• 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
• Patient Age: 71 YR
• Patient Weight: 54