• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR VENA CAVA FILTER Back to Search Results
Catalog Number RF320J
Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)
Event Date 12/04/2009
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Expiration date: 03/2012.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with bilateral deep vein thrombosis and pulmonary embolism. Approximately seven months later post filter deployment, it was alleged that the filter struts perforated, detached and patient was diagnosed with thrombosis and pulmonary embolism. The device has not been removed and there were no reported attempts made to retrieve the filter. The current status of the patient is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameG2 FILTER SYSTEM - JUGULAR
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 Key12187694
MDR Text Key262157977
Report Number2020394-2021-80578
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052578
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 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF320J
Device Lot NumberGFTB3660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2009
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: 07/19/2021 Patient Sequence Number: 1
Treatment
ALLOPURINOL, ROCEPHIN AND ZITHROMAX; FUROSEMIDE, CIPROFLOXACIN, TRIAMTERENE HCTZ, COREG; LASIX, LISINOPRIL, COUMADIN, LOVENOX; MEDROL DOSEPAK, ARIXTRA; NIFEDIPINE, VICODIN, FOLIC ACID, FERROUS SULFATE
-
-