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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2X FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problems Thrombus (2101); Thrombosis/Thrombus (4440)
Event Date 04/26/2017
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (expiry date: 07/2012).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident. At some time post filter deployment, it was alleged that the filter struts perforated. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient was diagnosed with thrombus at the level of the filter; however, the current status of the patient is unknown.
 
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Brand NameG2X FILTER SYSTEM - FEMORAL
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 Key11342519
MDR Text Key232351739
Report Number2020394-2021-80175
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082305
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF400F
Device Lot NumberGFTF3714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/18/2021 Patient Sequence Number: 1
Treatment
FUROSEMIDE, ALENDRONATE, ALPRAZOLAM; LISINOPRIL, AND CIPROFLOXACIN; METFORMIN, SIMVASTATIN, BISACODYL, ACETAMINOPHEN; ONDANSETRON, KLONOPIN, CITALOPRAM, WARFARIN; PANTOPRAZOLE, SENNA, DOCUSATE, PERCOCET
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