MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMASHIELD GOLD KNITTED DOUBLE VELOUR STRAIGHT GRAFT

Model Number	M002020951080
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) a review of the device history record has been performed.Its result 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 surgery performed on (b)(6) 2016, the graft was used as a conduit for a bypass for aortic root replacement.The graft was reported to weep, and surgical glue was used to stop the weeping.No additional information could be obtained at the date of this report.
Additional Manufacturer Narrative
((b)(4)) the device history records review was completed.It indicates that no nonconformance was recorded during the manufacturing process of the reported product lot number.((b)(4)) the graft was returned covered in blood and was inspected for the reported missing material.The miss material was unable to be confirmed due to the condition in which the graft was returned.Indeed, the complaint device was cleaned with saline before sending.((b)(4)) please note that, as per the product instructions for use, the graft was not used in an approved indication.
Event or Problem Description
The weeping was reported all along the graft.The surgeon suspected a miss of material.In addition, no adverse consequence for the patient was reported.
Additional Manufacturer Narrative
Correction : 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 GOLD KNITTED DOUBLE VELOUR STRAIGHT GRAFT
• Common Device Name: HEMASHIELD GOLD
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 5580347
• Report Number: 1640201-2016-00010
• Device Sequence Number: 562229
• Product Code: MAL
• UDI-Device Identifier: 00384401017363
• UDI-Public: 00384401017363
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K954848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2016

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: 08/31/2019
• Device Model Number: M002020951080
• Device Catalogue Number: M002020951080
• Device Lot Number: 25104055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/15/2016
• Supplement Report FDA Received Date: 06/28/2016; 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention