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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) G2X FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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C.R. BARD, INC. (GFO) G2X FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Great Vessel Perforation (2152)
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this lot number and failure mode. Medical records review: the patient with obesity and a history of deep vein thrombosis had a vena cava filter deployed below the level of the renal veins. A completion venacavagram demonstrated no extravasation. The patient tolerated the procedure well. Investigation summary: the device was not returned for evaluation. Images were not provided for review. Medical records were provided and reviewed. There was no specific deficiency alleged in the provided medical records. Therefore, the investigation is inconclusive for perforation as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based upon the available information, the definitive root cause is unknown. Labeling review: a review of product labeling documents (e. G. Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate. Expiration date: 11/2012. Manufacturing date: 01/2008. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before orthopedic procedure and due to a history of dvt. At some time post filter deployment, allegedly the filter perforated into duodenum causing obstruction and the patient was transferred to another hospital for filter retrieval. The device was removed percutaneously and a pancreaticoduodenectomy was performed. The status of the patient is unknown.

 
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Brand NameG2X FILTER SYSTEM - FEMORAL
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
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 Key7589884
MDR Text Key110701403
Report Number2020394-2018-00844
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK082305
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 07/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF400F
Device LOT NumberGFTJ1661
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 06/11/2018 Patient Sequence Number: 1
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