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

Model Number	F4006
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records were provided to the manufacturer.A video image was provided.The lot number for the device was provided.The device history records and video image are currently under review.The device was not returned to the manufacturer for evaluation.The investigation is currently under way.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that post implantation of an eptfe vascular graft, a two cm segment of the graft was allegedly weeping.The weeping fluid was discovered inter-operatively, post-implant of the vascular graft which required the use of a suction drain device.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was not returned.A video was provided.Based on the video review, leak is confirmed as the graft is seen leaking clear fluid.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that post implantation of an eptfe vascular graft, a two cm segment of the graft was allegedly weeping.The weeping fluid was discovered inter-operatively, post-implant of the vascular graft which required the use of a suction drain device.There was no reported patient injury.

• Brand Name: IMPRA EPTFE VASCULAR GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7505383
• Report Number: 2020394-2018-00650
• Device Sequence Number: 123686
• Product Code: DSY
• UDI-Device Identifier: 00801741022692
• UDI-Public: (01)00801741022692
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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: Health Professional
• Device Model Number: F4006
• Device Catalogue Number: F4006
• Device Lot Number: VTBR0150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 68