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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR; VENA CAVA FILTER Back to Search Results
Catalog Number RF320J
Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Injury (2348); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/29/2016
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record will not be performed.The device has not been returned to the manufacturer for evaluation.Therefore, the investigation of the reported event is currently underway.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with or before orthopedic procedure.At some time post filter deployment, it was alleged that filter struts perforated.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.
 
Manufacturer Narrative
H10: manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately eight years and one month post filter deployment, computed tomography (ct) revealed that a metallic fragment within the right ventricle.This possibly could be a fracture of previously placed filter.Therefore, the investigation is confirmed for filter limb detachment.However, the investigation is inconclusive for perforation of the inferior vena cava (ivc).Based on 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.H11:section a through f - the information provided by bd 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 bd.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with or before orthopedic procedure.At some time post filter deployment, it was alleged that filter struts perforated.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.
 
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Brand Name
G2 FILTER SYSTEM - JUGULAR
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key11336505
MDR Text Key232178704
Report Number2020394-2021-80168
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K052578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF320J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LISINOPRIL, SINGULAIR, ALBUTEROL, ESTRACE; LISINOPRIL, SINGULAIR, ALBUTEROL, ESTRACE; LOPRESSOR AND OMEPRAZOLE; LOPRESSOR AND OMEPRAZOLE; NORCO, VALIUM, OMEPRAZOLE, METOPROLOL TARTRATE; NORCO, VALIUM, OMEPRAZOLE, METOPROLOL TARTRATE; LISINOPRIL, SINGULAIR, ALBUTEROL, ESTRACE; LOPRESSOR AND OMEPRAZOLE; NORCO, VALIUM, OMEPRAZOLE, METOPROLOL TARTRATE
Patient Outcome(s) Other;
Patient Age74 YR
Patient Weight79
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