MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA CENTERFLEX EPTFE GRAFT; EPTFE VASCULAR GRAFT

Model Number	CF4006
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Swelling (2091); Fluid Discharge (2686); No Code Available (3191)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review will not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that during a graft placement procedure in the upper left extremity, the graft allegedly began leaking serous fluid.The problem eventually self-resolved and did not require other devices but further intervention was needed as a result.There was no reported patient injury.

• Brand Name: IMPRA CENTERFLEX EPTFE GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8648203
• Report Number: 2020394-2019-00658
• Device Sequence Number: 16608806
• Product Code: DSY
• UDI-Device Identifier: 00801741021916
• UDI-Public: (01)00801741021916
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2019

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: Health Professional
• Device Model Number: CF4006
• Device Catalogue Number: CF4006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/28/2019
• 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
• Patient Age: 67 YR
• Patient Weight: 65