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

Model Number	DF7007SC
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	11/09/2017
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 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: EPTFE GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7088517
• Report Number: 2020394-2017-01701
• Device Sequence Number: 1159405
• Product Code: DSY
• UDI-Device Identifier: 00801741023576
• UDI-Public: (01)00801741023576
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 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
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1