CARDIAC OCCLUSION DEVICE
This device is manufactured by AGA MEDICAL CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2019 | Unintended Movement | 11 | Device |
| 2019 | Retraction Problem | 2 | Device |
| 2019 | Positioning Problem | 1 | Device |
| 2019 | Patient-Device Incompatibility | 1 | Device |
| 2019 | Patient Device Interaction Problem | 2 | Device |
| 2019 | Obstruction of Flow | 1 | Device |
| 2019 | Migration or Expulsion of Device | 1 | Device |
| 2019 | Migration | 6 | Device |
| 2019 | Material Protrusion/Extrusion | 1 | Device |
| 2019 | Material Deformation | 69 | Device |
| 2019 | Leak/Splash | 1 | Device |
| 2019 | Insufficient Information | 3 | Device |
| 2019 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2019 | Failure to Disconnect | 1 | Device |
| 2019 | Difficult to Remove | 1 | Device |
| 2019 | Difficult or Delayed Positioning | 3 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2019 | Activation Failure | 1 | Device |
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Unintended Movement | 29 | Device |
| 2018 | Retraction Problem | 2 | Device |
| 2018 | Premature Activation | 1 | Device |
| 2018 | Positioning Problem | 1 | Device |
| 2018 | Perivalvular Leak | 1 | Device |
| 2018 | Patient Device Interaction Problem | 1 | Device |
| 2018 | Off-Label Use | 2 | Device |
| 2018 | Migration or Expulsion of Device | 11 | Device |
| 2018 | Material Erosion | 1 | Device |
| 2018 | Material Deformation | 58 | Device |
| 2018 | Leak/Splash | 2 | Device |
| 2018 | Insufficient Information | 4 | Device |
| 2018 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2018 | Expulsion | 1 | Device |
| 2018 | Difficult or Delayed Positioning | 1 | Device |
| 2018 | Biocompatibility | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 14 | Device |
| 2017 | Unintended Movement | 26 | Device |
| 2017 | Retraction Problem | 3 | Device |
| 2017 | Positioning Problem | 1 | Device |
| 2017 | Material Erosion | 4 | Device |
| 2017 | Material Deformation | 7 | Device |
| 2017 | Leak/Splash | 1 | Device |
| 2017 | Insufficient Information | 7 | Device |
| 2017 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2017 | Device Operates Differently Than Expected | 5 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
| 2016 | Unintended Movement | 20 | Device |
| 2016 | Migration or Expulsion of Device | 2 | Device |
| 2016 | Insufficient Information | 1 | Device |
| 2016 | Inadequacy of Device Shape and/or Size | 4 | Device |
| 2016 | Detachment of Device or Device Component | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2015 | Structural Problem | 1 | Device |
| 2015 | Positioning Problem | 1 | Device |
| 2015 | Insufficient Information | 2 | Device |
| 2015 | Device Operates Differently Than Expected | 1 | Device |
| 2015 | Device Dislodged or Dislocated | 1 | Device |
| 2014 | Unstable | 2 | Device |
| 2014 | Premature Activation | 1 | Device |
| 2014 | Positioning Problem | 2 | Device |
| 2014 | Partial Blockage | 1 | Device |
| 2014 | Occlusion Within Device | 3 | Device |
| 2014 | Obstruction of Flow | 1 | Device |
| 2014 | Migration or Expulsion of Device | 11 | Device |
| 2014 | Material Erosion | 1 | Device |
| 2014 | Material Deformation | 1 | Device |
| 2014 | Loose or Intermittent Connection | 1 | Device |
| 2014 | Insufficient Information | 3 | Device |
| 2014 | Infusion or Flow Problem | 1 | Device |
| 2014 | Inadequacy of Device Shape and/or Size | 1 | Device |
| 2014 | Difficult to Remove | 2 | Device |
| 2014 | Difficult or Delayed Positioning | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 2 | Device |
| 2014 | Device Dislodged or Dislocated | 3 | Device |
| 2014 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2014 | Detachment Of Device Component | 2 | Device |
| 2014 | Defective Device | 1 | Device |
| 2014 | Component Falling | 1 | Device |
| 2014 | Break | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2013 | Obstruction of Flow | 1 | Device |
| 2013 | Migration or Expulsion of Device | 1 | Device |
| 2013 | Extrusion | 1 | Device |
| 2013 | Difficult to Insert | 1 | Device |
| 2013 | Device Dislodged or Dislocated | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 1 | Device |