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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative

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. There were no device deficiencies identified within the medical records. Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter. 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.

 
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. There was no specific device malfunction reported. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient reportedly expired.

 
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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 Key10981749
MDR Text Key220622833
Report Number2020394-2020-06488
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 12/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2020
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
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: 12/10/2020 Patient Sequence Number: 1
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