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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2X FILTER VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2X FILTER VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
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 the three malfunctions and lot history reviews were performed. The devices for 3 malfunctions were not returned for evaluation, however, medical records were provided and reviewed. One malfunction was confirmed for perforation but was inconclusive for tilt. The second malfunction was confirmed for perforation and tilt, and the third malfunction is still pending. The devices are labeled for single use.

 
Event Description

This report summarizes three malfunctions. A review of the reported information indicated that model rf400f vena cava filter was allegedly tilt and perforation. This information was received from various sources. The three malfunctions involved three patients with no patient consequences. The age of the reported patients ranged from 51-68 years old. Two patients were female and one was male. The weight of the patients was not provided.

 
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Brand NameG2X 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 Key10314578
MDR Text Key200203852
Report Number2020394-2020-05002
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 07/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberRF400F
Device LOT NumberGFTL0894, GFUA2472, GFUA2475
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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