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

Catalog Number DFM6006SC

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2014

Event Type  Injury  

Manufacturer Narrative

A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803.The lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a mfg related cause for this event.The investigation is confirmed for torn material, as the returned sample exhibited several flared out longitudinal tears along the cuffed edge of the graft that appeared to be suture line tears.The investigation is inconclusive for the leak, as the graft could not be functionally tested.It is unk if procedural issues contributed to the reported event.Based on the available info, the definitive root cause is unk.

Event Description

It was reported that during a bypass graft implantation from the femoral artery to the popliteal artery, the bypass graft was discovered to be leaking at the cuff suture site when full blood flow was released.The bypass graft was explanted.Another bypass graft was successfully implanted.There was no known impact or consequence to pt.

• Brand Name: DISTAFLO BYPASS GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR (BPV); na; na
• Manufacturer Contact: brett curtice ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4810634
• MDR Text Key: 15373176
• Report Number: 2020394-2015-00610
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K983861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: DFM6006SC
• Device Lot Number: 21755862
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2015
• Initial Date FDA Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR