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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER VENA CAVA FILTER Back to Search Results
Catalog Number EC500F
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The lot number was provided for 6 out of 10 malfunctions, therefore, lot history reviews were performed. The devices were not returned to the manufacturer for evaluation; however medical records were provided and reviewed for all the ten malfunctions and one of the medical records included images. For 8 of the 10 malfunctions, the investigation is confirmed for perforation and filter tilt. For 2 of the 10 malfunctions, the investigation is confirmed for perforation, but is inconclusive for filter tilt. Based on the available information, the definitive root cause is unknown. The devices are labeled for single use. (corporate lot no: gfuc2311, gfwd2824, gfvl0179, unknown).

 
Event Description

This report summarizes ten malfunctions. A review of the reported information indicated that model ec500f vena cava filter allegedly experienced tilt and perforation. This information was received from various sources. All ten malfunctions were involved with no patient consequences. The 10 patients ranged from 41-84 years of age. Of the reported patients, 5 are male and 4 are female. Weight and gender for the remaining patient's were not provided.

 
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Brand NameECLIPSE FILTER
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10302949
MDR Text Key199716076
Report Number2020394-2020-04756
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberEC500F
Device LOT NumberGFWK2804, GFVF2213, GFUI2696
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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