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

Model Number	M00202175208P0
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Review of the complaint device history records is ongoing, results are pending.(b)(4).The complaint device has been received and will be inspected by our qa supervisor.(b)(4).The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Before axillary anastomosis, the surgeon found that the graft was bent, with a different shape from what he used to see.After cutting the strange part, the surgeon still felt something was wrong.So he replaced the concerned graft with another same model graft.
Additional Manufacturer Narrative
(3331/213) a review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.These tests include a 100% visual inspection of the graft.(4109/213) the review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.(10/170) a visual inspection of the complaint device was performed by our quality assurance (qa) supervisor.A deformation at one end of the graft was confirmed.This deformation was probably performed during manufacturing steps.(25) the conducted investigation indicated that the issue was probably related to human errors during manufacturing steps.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.

• Brand Name: HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; z.i. athelia i; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 7730552
• Report Number: 1640201-2018-00018
• Device Sequence Number: 2542200
• Product Code: MAL
• UDI-Device Identifier: 00384401018148
• UDI-Public: 00384401018148
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: 01/31/2023
• Device Model Number: M00202175208P0
• Device Catalogue Number: M00202175208P0
• Device Lot Number: 18B07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1