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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 X FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problems Extrusion (2934); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2017
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Investigation summary: the device was not returned for evaluation. Images and medical records were not provided for review. 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. 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 some time post vena cava filter deployment a ct scan demonstrated that the filter perforated. There were no reported attempts made to retrieve the filter. The status of the patient is unknown.

 
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Brand NameG2 X 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 Key7567490
MDR Text Key110032920
Report Number2020394-2018-00802
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF400F
Device LOT NumberGFTG2528
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
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

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