MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR GRAFT; VASCULAR POLYESTER GRAFT

Model Number	M00202175430P0
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ((b)(4)): a review of the device history records indicated that the graft was processed and inspected according to procedures and no anomaly was found.No conclusion can be drawn.However, the conducted investigation would tend to indicate that the product was not defective at the time of manufacturing.Please note that it is commonly accepted among vascular surgeons that woven grafts are prone to fraying.For that purpose, precautions when cutting the graft are clearly mentioned in the instructions for use.Therefore, it is considered as probable that a lack of precaution from the user has contributed to this event.
Event or Problem Description
During a vascular procedure performed on (b)(6) 2016, it was reported that the graft frayed after trimming it and beginning the suture.The portion of the frayed graft was trimmed and the anastomosis was successfully completed.No adverse effect for the patient was reported.

• Brand Name: HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR GRAFT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6278798
• Report Number: 1640201-2017-00002
• Device Sequence Number: 19114740
• Product Code: MAL
• UDI-Device Identifier: 00384401018254
• UDI-Public: 00384401018254
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2016

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: 08/31/2021
• Device Model Number: M00202175430P0
• Device Catalogue Number: M00202175430P0
• Device Lot Number: 16J14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2016
• Initial Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1