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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. IMPRA STRAIGHT EPTFE GRAFT Back to Search Results
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.

 
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Brand NameIMPRA 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 Key4811429
MDR Text Key5928738
Report Number2020394-2015-00608
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberK983064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE,FOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/22/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number70S07
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/06/2014
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2015
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

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