MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DISTAFLO MINI-CUFF BYPASS GRAFT; EPTFE VASCULAR GRAFT

Catalog Number DFX8006SC

Device Problems Material Fragmentation (1261); Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2013

Event Type  malfunction  

Event Description

It was reported that during a surgical graft implantation, the graft tore into several pieces while being sutured into the vessel; however, the graft was modified during the procedure and sutured into the vessel successfully without further incident.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records were reviewed.The 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 for this lot number and issue to date.Visual inspection: the graft was returned in 2 separate segments.Blue lines and carbon lining were identified on both segments which confirms that this is a bard graft.Segment 1: segment one measured approximately 80mm in length.There was no beading removed from this portion and no suture holes observed.The ends of the graft appeared trimmed.No tears and/or rips were noted on this segment.Segment 2: segment two measured approximately 270mm in length.There was no beading removed from this portion.A suture and suture holes were present on the left side of the graft segment.A partial circumferential tear was located approximately 6mm from the left edge of the graft.Functional/performance evaluation: no functional testing was performed.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the investigation is confirmed for a partial circumferential tear.It is unknown if procedural issues contributed to the reported event.Based on the available information, the definitive root cause is unknown.Labeling review: the current distaflo mini-cuff bypass graft instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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.

• Brand Name: DISTAFLO MINI-CUFF BYPASS GRAFT
• Type of Device: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5355393
• MDR Text Key: 35922151
• Report Number: 2020394-2016-00060
• Device Sequence Number: 1
• Product Code: DYF
• Combination Product (y/n): N
• PMA/PMN Number: K983769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: DFX8006SC
• Device Lot Number: VTW122581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 56