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

Model Number DFX7006SC

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.A potential manufacturing change 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 returned segment had the beading of the graft removed throughout the length of the segment.Two tears were noted along the beading track of the returned segment.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 current ifu states: precautions: when removing the external spiral support (beading) of the distaflo® graft, the beading must be removed slowly and at a 90° angle to the graft.Rapid unwinding and /or removal at less than a 90° angle may result in graft damage.Do not use surgical blades or sharp, pointed instruments to remove the beading as this may damage the graft wall.If damage occurs, that segment of the graft should not be used.Aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage.The distal anastomosis should be made after tunneling or suture disruption can occur.Do not pass the cuff portion (distal end) of the distaflo bypass graft through a tunneler sheath or the tissue tunnel, as this could lead to separation of the spiral beading and/or graft breakage.Distaflo bypass grafts do not stretch (are non-elastic) in the longitudinal direction.The correct graft length for each procedure must be determined by considering the patient's body weight, posture, and the range of motions across the anatomical area of graft implantation.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 Description

It was reported that during intraoperative beading removal, holes in the graft were allegedly identified at the site of the removed beading.It was further reported that the health care provider revised the graft and removed the affected segment.Reportedly, the procedure was completed with the same device.There was no reported patient injury.

• Brand Name: DISTAFLO BYPASS GRAFT
• Type of Device: DISTAFLO BYPASS GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7347155
• MDR Text Key: 102722533
• Report Number: 2020394-2018-00242
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741023668
• UDI-Public: (01)00801741023668
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K983769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2022
• Device Model Number: DFX7006SC
• Device Catalogue Number: DFX7006SC
• Device Lot Number: VTBP0152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2017
• 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