CLAMPLESS BEATING HEART
This device is manufactured by BOSTON SCIENTIFIC CORPORATION, MAQUET CARDIOVASCULAR.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2023 | Fitting Problem | 1 | Device |
| 2023 | Activation Problem | 1 | Device |
| 2019 | Therapeutic or Diagnostic Output Failure | 2 | Device |
| 2019 | Physical Resistance/Sticking | 2 | Device |
| 2019 | Misfire | 1 | Device |
| 2019 | Material Deformation | 1 | Device |
| 2019 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2019 | Incorrect Measurement | 1 | Device |
| 2019 | Fitting Problem | 4 | Device |
| 2019 | Firing Problem | 1 | Device |
| 2019 | Failure to Unfold or Unwrap | 1 | Device |
| 2019 | Difficult to Insert | 1 | Device |
| 2019 | Detachment of Device or Device Component | 2 | Device |
| 2019 | Crack | 1 | Device |
| 2019 | Activation, Positioning or Separation Problem | 6 | Device |
| 2019 | Activation Problem | 3 | Device |
| 2018 | Use of Device Problem | 2 | Device |
| 2018 | Structural Problem | 2 | Device |
| 2018 | Positioning Problem | 1 | Device |
| 2018 | Positioning Failure | 4 | Device |
| 2018 | Physical Resistance/Sticking | 1 | Device |
| 2018 | Physical Resistance | 1 | Device |
| 2018 | Mechanics Altered | 1 | Device |
| 2018 | Mechanical Problem | 2 | Device |
| 2018 | Material Frayed | 1 | Device |
| 2018 | Loose or Intermittent Connection | 1 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2018 | Firing Problem | 3 | Device |
| 2018 | Entrapment of Device | 2 | Device |
| 2018 | Difficult to Remove | 1 | Device |
| 2018 | Difficult to Insert | 1 | Device |
| 2018 | Difficult to Fold, Unfold or Collapse | 1 | Device |
| 2018 | Device Slipped | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 8 | Device |
| 2018 | Device Inoperable | 1 | Device |
| 2018 | Device Fell | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 4 | Device |
| 2018 | Crack | 1 | Device |
| 2018 | Component Falling | 4 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Activation, Positioning or Separation Problem | 19 | Device |
| 2017 | Sticking | 1 | Device |
| 2017 | Positioning Problem | 1 | Device |
| 2017 | Positioning Failure | 7 | Device |
| 2017 | Misfire | 2 | Device |
| 2017 | Migration or Expulsion of Device | 1 | Device |
| 2017 | Mechanical Problem | 1 | Device |
| 2017 | Malposition of Device | 3 | Device |
| 2017 | Loose or Intermittent Connection | 1 | Device |
| 2017 | Fitting Problem | 1 | Device |
| 2017 | Failure to Align | 1 | Device |
| 2017 | Failure to Advance | 2 | Device |
| 2017 | Difficult to Open or Close | 2 | Device |
| 2017 | Difficult to Insert | 4 | Device |
| 2017 | Difficult or Delayed Positioning | 2 | Device |
| 2017 | Device Operates Differently Than Expected | 29 | Device |
| 2017 | Device Inoperable | 1 | Device |
| 2017 | Crack | 7 | Device |
| 2017 | Component Falling | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2017 | Activation, Positioning or Separation Problem | 2 | Device |
| 2016 | Positioning Failure | 3 | Device |
| 2016 | Peeled/Delaminated | 1 | Device |
| 2016 | Mechanical Problem | 1 | Device |
| 2016 | Malposition of Device | 2 | Device |
| 2016 | Failure to Advance | 1 | Device |
| 2016 | Entrapment of Device | 1 | Device |
| 2016 | Difficult to Remove | 1 | Device |
| 2016 | Difficult or Delayed Positioning | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 12 | Device |
| 2016 | Device Dislodged or Dislocated | 1 | Device |
| 2016 | Crack | 3 | Device |
| 2016 | Activation, Positioning or Separation Problem | 3 | Device |
| 2015 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2015 | Positioning Failure | 3 | Device |
| 2015 | Fitting Problem | 14 | Device |
| 2014 | Positioning Failure | 3 | Device |
| 2014 | Leak/Splash | 2 | Device |
| 2014 | Fitting Problem | 12 | Device |
| 2014 | Failure To Adhere Or Bond | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 4 | Device |
| 2014 | Device Difficult to Setup or Prepare | 2 | Device |
| 2014 | Crack | 5 | Device |
| 2013 | Unraveled Material | 1 | Device |
| 2013 | Premature Activation | 1 | Device |
| 2013 | Positioning Failure | 1 | Device |
| 2013 | Mechanical Problem | 1 | Device |
| 2013 | Fitting Problem | 1 | Device |
| 2013 | Device Operates Differently Than Expected | 6 | Device |
| 2013 | Device Difficult to Setup or Prepare | 2 | Device |
| 2013 | Crack | 1 | Device |