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

Model Number DF7007SC

Device Problem Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/09/2017

Event Type  malfunction  

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 device was 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 Description

It was reported that prior to placement of the eptfe vascular graft, the graft allegedly tore upon removal of the spiral beading.Another device was used to complete the procedure.There was no patient contact.

Manufacturer Narrative

A manufacturing review was performed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was returned for evaluation.The distal end of the graft was noted to have two tears along the beading track.Therefore, the investigation is confirmed for the alleged torn material.The definitive root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Labeling review:the current ifu states: when removing the external spiral support (beading) of the 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.

Event Description

It was reported that prior to placement of the eptfe vascular graft, the graft allegedly tore upon removal of the spiral beading.Reportedly, another vascular graft was used to complete the procedure.There was no patient contact.

• Brand Name: DISTAFLO BYPASS GRAFT
• Type of Device: EPTFE 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: 7088517
• MDR Text Key: 94518951
• Report Number: 2020394-2017-01701
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741023576
• UDI-Public: (01)00801741023576
• 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,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2021
• Device Model Number: DF7007SC
• Device Catalogue Number: DF7007SC
• Device Lot Number: VTAU0590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• 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