MAUDE Adverse Event Report: INTERVASCULAR SAS CARDIOROOT WOVEN; VASCULAR POLYESTER GRAFT

Model Number	HEWROOT0034
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): a review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to established procedures and no anomaly was found.Specifically, the review of the mechanical test results obtained on the same fabric as the complaint device indicated values within product specifications.(b)(4): no conclusion can be drawn.However, the conducted investigation would tend to indicate that the product was not defective at the time of manufacturing.(b)(4): please note that precautions when cutting the graft are clearly mentioned in the warning section of the instructions for use "due to their intrinsic weaving pattern, woven grafts are more prone to fraying when cut with scissors.As with all woven products, a low-temperature disposable cautery should be used to minimize fraying when cutting this graft".Therefore, it is considered as probable that an user error has contributed to this event.
Event or Problem Description
The hospital reported that during a cardioroot graft procedure, surgeon experienced some graft fraying at the point where he used scissors to trim the graft for length.No negative patient outcome was reported.The graft was implanted.

• Brand Name: CARDIOROOT WOVEN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 6493157
• Report Number: 1640201-2017-00007
• Device Sequence Number: 1269100
• Product Code: DSY
• UDI-Device Identifier: 00384401013938
• UDI-Public: 00384401013938
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K103347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/14/2017

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: 08/31/2019
• Device Model Number: HEWROOT0034
• Device Catalogue Number: HEWROOT0034
• Device Lot Number: 14J11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1