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

Model Number	DFX8006SC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.
Event or Problem Description
It was reported that during placement of the vascular graft, the graft allegedly tore upon removal of the spiral beading.The torn material of the vascular graft was removed to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during placement of the vascular graft, the graft allegedly tore upon removal of the spiral beading.The torn material of the vascular graft was removed to complete the procedure.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.A potential manufacturing changes could have contributed to the identified issue.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: a segment of graft was returned for evaluation.The beading was completely removed from the returned segment.Multiple circumferential tears were noted along the beading imprints and one longitudinal tear was noted.Therefore, the investigation is confirmed for torn material.The definitive root cause for the identified tear along the bead track is unknown.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.

• Brand Name: DISTAFLO EPTFE VASCULAR GRAFT
• Common Device Name: DISTAFLO BYPASS GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7970823
• Report Number: 2020394-2018-01912
• Device Sequence Number: 16537063
• Product Code: DSY
• UDI-Device Identifier: 00801741023675
• UDI-Public: (01)00801741023675
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: DFX8006SC
• Device Catalogue Number: DFX8006SC
• Device Lot Number: VTCQ0519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1