MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMASHIELD GOLD KNITTED GRAFT; VASCULAR POLYESTER GRAFT

Model Number	M002020851690
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records was reviewed.It indicates that no nonconformance was recorded during the manufacturing process of the reported product lot number.No conclusion can be drawn.However, the conducted investigation would tend to indicate that the product was not defective.
Event or Problem Description
During an abdominal aneurysm surgery performed on (b)(6) 2016, blood leak was noted from the bifurcation of the main graft segment.Astriction and gauze application were performed to stop the bleeding.The bleeding was finally stopped by administration of protamine.The graft remained implanted, without any adverse outcome for the patient.
Additional Manufacturer Narrative
Unique identifier (udi) number is not applicable for the involved device.This correction is done following the review of the complaint file for closure.

• Brand Name: HEMASHIELD GOLD KNITTED GRAFT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 5781625
• Report Number: 1640201-2016-00017
• Device Sequence Number: 13612718
• Product Code: MAL
• UDI-Device Identifier: 00384401017738
• UDI-Public: 00384401017738
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 06/30/2017
• Device Model Number: M002020851690
• Device Catalogue Number: M002020851690
• Device Lot Number: 25059983
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention