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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD G2X FILTER

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BARD G2X FILTER Back to Search Results
Device Problems Fracture (1260); Occlusion Within Device (1423)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/15/2017
Event Type  Injury  
Event Description
G2x filter placed in 2009 found recently to be fractured and embolized. One fragment retained locally (half of leg), one embolized to left pulmonary artery (other half of leg) and one to the right ventricle entirely embedded in tissue of septum and moderator band. Pt asymptomatic. Removed all but cardiac fragment which is inaccessible, have recommended leaving in place with serial fu. Ct surgery consult said same.
 
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Brand NameG2X
Type of DeviceFILTER
Manufacturer (Section D)
BARD
tempe AZ
MDR Report Key6339165
MDR Text Key67825928
Report NumberMW5067935
Device Sequence Number1
Product Code DTK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/15/2017 Patient Sequence Number: 1
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