MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD CAROTID PATCH KNITTED ULTRATHIN; VASCULAR POLYESTER GRAFT

Model Number	HGKTP08/75CPUT
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the complaint device history records indicated that the patch was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Specifically, these tests include mechanical strength tests (longitudinal tensile strength and 45° and 90° suture retention strength) and 100% visual control.The actual device was cut out before returning to the manufacturer and was received incomplete in a bottle bathing in undefined liquid.Hence, evaluation of the edges in order to confirm fraying is impossible.Three other sealed products from same lot (including two patches from same intermediate product) were returned with the complaint device and were visually inspected.No anomaly was found.The complaint cannot be confirmed due to the condition of the received device which makes evaluation impossible.However, the conducted investigation would tend to indicate that the product was not defective at the time of manufacturing.
Event or Problem Description
The patch was frayed.
Additional Manufacturer Narrative
(10/213) the complaint device was inspected by our textile manufacturing supervisor.No structural defects were observed and the difficulty of assessing the edges due to product condition was confirmed.(10/114) the complaint was also reviewed by one of our senior r&d engineer.Due to the particular weaving structure, the likelihood of fraying in a knitted patch is low and the most probable root cause is an operational problem when suturing the patch.(4109/213) the review of post-marketing historical data indicated that no similar complaint was received for knitted patches for the last 10 years.(61) the conducted investigation would tend to indicate that the product was meeting its specification at the time of manufacturing and that an unintended use error probably caused the event.

• Brand Name: HEMAGARD CAROTID PATCH KNITTED ULTRATHIN
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7604972
• Report Number: 1640201-2018-00017
• Device Sequence Number: 1695082
• Product Code: DSY
• UDI-Device Identifier: 00384401015208
• UDI-Public: 00384401015208
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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: 09/30/2022
• Device Model Number: HGKTP08/75CPUT
• Device Catalogue Number: HGKTP08/75CPUT
• Device Lot Number: 17K05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1