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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER VENA CAVA FILTER Back to Search Results
Catalog Number RF320J
Device Problems Obstruction of Flow (2423); 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 the reported malfunction; therefore, a lot history review was performed. The sample was not returned to the manufacturer for evaluation. However, medical records were provided and reviewed. Therefore, the investigation is confirmed for the perforation of the ivc, filter malposition and occlusion of the ivc filter. Based upon the available information, the definitive root cause for this event is unknown. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicates that model rf320j vena cava filter allegedly experienced obstruction, malposition of device and patient device interaction problem. The information was received from one source. One patient was involved with no reported patient injury. The male patient was (b)(6) and weight not provided.

 
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Brand NameG2 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 Key10306262
MDR Text Key199843830
Report Number2020394-2020-04814
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 Received07/22/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberRF320J
Device LOT NumberGFRE3443
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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