MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VENAFLO II BYPASS GRAFT; EPTFE VASCULAR GRAFT

Model Number	VL4006C
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 during preparation of a surgical graft, a tear at the distal end of the graft occurred.A new surgical graft was prepped and implanted without incident.There was no reported patient involvement.
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.Small tears were noted along the cuff of the returned graft.Therefore, the investigation can be confirmed for torn material.Based upon the available information, the definitive root cause is unknown.Labeling review: the current instruction for use (ifu) states: trimming recommendations hold the graft with the cuff in an open configuration, as shown in figure 1.Using curved scissors, start trimming the cuff on the dashed line located nearest the heel.Continue trimming on the dashed lines following the curvature suggested.Note: do not fold the graft cuff in half when trimming.Do not trim material from the heel.
Event or Problem Description
It was reported that during preparation of a surgical graft, a tear at the distal end of the graft occurred.A new surgical graft was prepped and implanted without incident.There was no reported patient involvement.

• Brand Name: VENAFLO II BYPASS GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6723604
• Report Number: 2020394-2017-00813
• Device Sequence Number: 187498
• Product Code: DSY
• UDI-Device Identifier: 00801741020438
• UDI-Public: (01)00801741020438
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K052282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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 Expiration Date: 02/09/2021
• Device Model Number: VL4006C
• Device Catalogue Number: VL4006C
• Device Lot Number: VTAP0402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1