MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA STRAIGHT EPTFE GRAFT

Catalog Number 70S07

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2013

Event Type  malfunction  

Event Description

It was reported that during a surgical graft implantation, blood was leaking through several segments of the graft; therefore, the surgical graft was removed and exchanged for a new surgical graft that was implanted successfully without incident.There was no reported pt injury.

Manufacturer Narrative

A manufacturing review was not conducted as the lot number is unk.The complaint investigation is inconclusive to graft leak, as the reported conditions of use could not be recreated.The definitive root cause could not be determined based upon available info.It is unk whether the pt and/or procedural issues contributed to the event.The results of the investigation concluded that the complaint trend and the threshold are not applicable as there are no other similar complaints reported.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.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The international representative was able to provide new patient information which was updated in the appropriate sections.

• Brand Name: IMPRA STRAIGHT EPTFE GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4811429
• MDR Text Key: 5928738
• Report Number: 2020394-2015-00608
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K983064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,for
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 70S07
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 85 YR
• Patient Weight: 58