MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMASHIELD PLATINUM WOVEN BIFURCATED GRAFT; VASCULAR POLYESTER GRAFT

Model Number	M00202166241P0
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is being performed.Its conclusion is not available at the date of this report.The investigation is still on-going.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
During the preparation of an abdominal aortic surgery performed on (b)(6) 2016, the graft was reported to fray and was not implanted.
Additional Manufacturer Narrative
The device history records review was completed.It indicates that no nonconformance was recorded during the manufacturing process of the reported product lot number.The returned device was inspected on june 28, 2016.Fraying at the bottom of the graft main trunk was confirmed.There was no blood and no evidence that the graft was cut.No other nonconformance was observed.Therefore, the product, as it was received, does not comply with the specification.No conclusion can be drawn.The root cause is undetermined.However, the outcome of the investigation would tend to indicate that the product was not defective at the time of manufacturing.
Additional Manufacturer Narrative
Unique identifier (udi) number is not applicable for the involved device which was manufactured before september 2015.This correction is done following the review of the complaint file for closure.

• Brand Name: HEMASHIELD PLATINUM WOVEN BIFURCATED GRAFT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 5662640
• Report Number: 1640201-2016-00013
• Device Sequence Number: 18836073
• Product Code: MAL
• UDI-Device Identifier: 00384401018520
• UDI-Public: 00384401018520
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2016

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: 03/31/2019
• Device Model Number: M00202166241P0
• Device Catalogue Number: M00202166241P0
• Device Lot Number: 25095437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/19/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 07/05/2016; 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1