GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

This device is manufactured by COOK MEDICAL.

The following problems were reported about this device:

Year Description Events/year Type
2023 Thrombosis/Thrombus 1 Patient
2023 Perforation of Vessels 3 Patient
2023 Pain 2 Patient
2023 Numbness 1 Patient
2023 Internal Organ Perforation 8 Patient
2023 Insufficient Information 1 Patient
2023 Foreign Body In Patient 1 Patient
2023 Dyspnea 1 Patient
2023 Device Embedded In Tissue or Plaque 3 Patient
2023 Depression 1 Patient
2023 Cognitive Changes 1 Patient
2023 Chest Pain 1 Patient
2023 Anxiety 2 Patient
2023 Ambulation Difficulties 1 Patient
2023 Unintended Movement 4 Device
2023 Structural Problem 12 Device
2023 Obstruction of Flow 2 Device
2023 Migration or Expulsion of Device 4 Device
2023 Migration 2 Device
2023 Malposition of Device 1 Device
2023 Insufficient Information 17 Device
2023 Fracture 3 Device
2023 Difficult to Remove 16 Device
2023 Device Tipped Over 9 Device
2023 Detachment of Device or Device Component 3 Device
2023 Appropriate Term/Code Not Available 30 Device
2023 Adverse Event Without Identified Device or Use Problem 2 Device
2022 Unintended Movement 5 Device
2022 Structural Problem 18 Device
2022 Obstruction of Flow 10 Device
2022 Migration or Expulsion of Device 1 Device
2022 Insufficient Information 14 Device
2022 Inadequate Filtration Process 4 Device
2022 Entrapment of Device 1 Device
2022 Difficult to Remove 8 Device
2022 Device Tipped Over 12 Device
2022 Appropriate Term/Code Not Available 17 Device
2022 Adverse Event Without Identified Device or Use Problem 2 Device
2021 Unintended Movement 3 Device
2021 Structural Problem 3 Device
2021 Migration 1 Device
2021 Insufficient Information 5 Device
2021 Inadequate Filtration Process 1 Device
2021 Fracture 1 Device
2021 Difficult to Remove 3 Device
2021 Device Tipped Over 1 Device
2021 Appropriate Term/Code Not Available 5 Device
2021 Adverse Event Without Identified Device or Use Problem 1 Device
2020 Unintended Movement 3 Device
2020 Structural Problem 3 Device
2020 Insufficient Information 12 Device
2020 Inadequate Filtration Process 1 Device
2020 Difficult to Remove 8 Device
2020 Device Tipped Over 1 Device
2020 Appropriate Term/Code Not Available 8 Device
2020 Adverse Event Without Identified Device or Use Problem 3 Device
2019 Unintended Movement 27 Device
2019 Migration or Expulsion of Device 11 Device
2019 Migration 4 Device
2019 Malposition of Device 2 Device
2019 Insufficient Information 127 Device
2019 Fracture 6 Device
2019 Entrapment of Device 4 Device
2019 Difficult to Remove 66 Device
2019 Defective Device 1 Device
2019 Complete Blockage 1 Device
2019 Appropriate Term/Code Not Available 125 Device
2019 Adverse Event Without Identified Device or Use Problem 14 Device
2018 Unintended Movement 49 Device
2018 Migration or Expulsion of Device 13 Device
2018 Material Rupture 1 Device
2018 Malposition of Device 2 Device
2018 Insufficient Information 126 Device
2018 Fracture 9 Device
2018 Entrapment of Device 1 Device
2018 Difficult to Remove 71 Device
2018 Device Operational Issue 1 Device
2018 Device Operates Differently Than Expected 1 Device
2018 Device Issue 1 Device
2018 Appropriate Term/Code Not Available 55 Device
2018 Adverse Event Without Identified Device or Use Problem 8 Device
2017 Perforation of Vessels 1 Patient
2017 Dyspnea 1 Patient
2017 Chest Pain 1 Patient
2017 Anxiety 1 Patient
2017 Unintended Movement 43 Device
2017 Structural Problem 1 Device
2017 Occlusion Within Device 1 Device
2017 Migration or Expulsion of Device 15 Device
2017 Material Perforation 1 Device
2017 Malposition of Device 5 Device
2017 Insufficient Information 138 Device
2017 Fracture 5 Device
2017 Entrapment of Device 2 Device
2017 Difficult to Remove 78 Device
2017 Complete Blockage 1 Device
2017 Appropriate Term/Code Not Available 5 Device
2017 Adverse Event Without Identified Device or Use Problem 21 Device
2016 Unintended Movement 3 Device
2016 Migration or Expulsion of Device 4 Device
2016 Material Frayed 1 Device
2016 Insufficient Information 8 Device
2016 Fracture 1 Device
2016 Difficult to Remove 6 Device
2016 Appropriate Term/Code Not Available 3 Device
2016 Adverse Event Without Identified Device or Use Problem 4 Device
2015 Unintended Movement 4 Device
2015 Structural Problem 1 Device
2015 Migration or Expulsion of Device 4 Device
2015 Malposition of Device 5 Device
2015 Insufficient Information 6 Device
2015 Fracture 4 Device
2015 Difficult to Remove 12 Device
2015 Device Tipped Over 1 Device
2015 Appropriate Term/Code Not Available 4 Device
2015 Adverse Event Without Identified Device or Use Problem 3 Device
2014 Unintended Movement 1 Device
2014 Structural Problem 1 Device
2014 Obstruction of Flow 1 Device
2014 Migration or Expulsion of Device 1 Device
2014 Migration 1 Device
2014 Insufficient Information 4 Device
2014 Difficult to Remove 6 Device
2014 Detachment of Device or Device Component 1 Device
2014 Appropriate Term/Code Not Available 1 Device
2014 Adverse Event Without Identified Device or Use Problem 2 Device
2013 Structural Problem 1 Device
2013 Obstruction of Flow 1 Device
2013 Migration or Expulsion of Device 1 Device
2013 Malposition of Device 1 Device
2013 Insufficient Information 1 Device
2013 Difficult to Remove 1 Device
2013 Device Tipped Over 1 Device
2013 Appropriate Term/Code Not Available 1 Device
2013 Adverse Event Without Identified Device or Use Problem 1 Device
2012 Malposition of Device 1 Device
2012 Kinked 2 Device
2012 Insufficient Information 2 Device
2012 Failure to Advance 2 Device
2012 Difficult to Remove 3 Device
2012 Appropriate Term/Code Not Available 1 Device
2012 Adverse Event Without Identified Device or Use Problem 1 Device
2012 Activation Failure 1 Device
2011 Perforation of Vessels 1 Patient
2011 Unintended Movement 3 Device
2011 Structural Problem 1 Device
2011 Migration or Expulsion of Device 3 Device
2011 Malposition of Device 3 Device
2011 Insufficient Information 4 Device
2011 Entrapment of Device 1 Device
2011 Difficult to Remove 7 Device
2011 Adverse Event Without Identified Device or Use Problem 2 Device
2010 Migration or Expulsion of Device 2 Device
2010 Insufficient Information 3 Device
2010 Entrapment of Device 1 Device
2010 Difficult to Remove 7 Device
2010 Appropriate Term/Code Not Available 1 Device
2010 Adverse Event Without Identified Device or Use Problem 4 Device
2009 Unintended Movement 3 Device
2009 Migration or Expulsion of Device 1 Device
2009 Insufficient Information 2 Device
2009 Fracture 1 Device
2009 Difficult to Remove 3 Device
2008 Entrapment of Device 1 Device
2008 Difficult to Remove 1 Device
2007 Insufficient Information 1 Patient
2007 Unintended Movement 1 Device
2007 Insufficient Information 2 Device
2007 Difficult to Remove 4 Device
2007 Appropriate Term/Code Not Available 1 Device
2006 Unintended Movement 1 Device
2006 Migration or Expulsion of Device 1 Device
2006 Insufficient Information 2 Device
2006 Difficult to Remove 2 Device
2006 Adverse Event Without Identified Device or Use Problem 1 Device
2005 Migration or Expulsion of Device 1 Device
2005 Malposition of Device 1 Device
2005 Insufficient Information 1 Device
2005 Fracture 1 Device
2004 Insufficient Information 1 Device
2004 Difficult to Remove 1 Device
2002 Difficult to Remove 1 Device
2002 Appropriate Term/Code Not Available 1 Device