CATHETER, CORONARY, ATHERECTOMY
This device is manufactured by BOSTON SCIENTIFIC - CORK.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2018 | Torn Material | 1 | Device |
| 2018 | Physical Resistance/Sticking | 1 | Device |
| 2018 | Physical Resistance | 1 | Device |
| 2018 | Packaging Problem | 1 | Device |
| 2018 | Mechanical Problem | 2 | Device |
| 2018 | Mechanical Jam | 1 | Device |
| 2018 | Material Split, Cut or Torn | 2 | Device |
| 2018 | Material Rupture | 5 | Device |
| 2018 | Hole In Material | 2 | Device |
| 2018 | Gas/Air Leak | 1 | Device |
| 2018 | Fluid/Blood Leak | 6 | Device |
| 2018 | Failure to Advance | 3 | Device |
| 2018 | Erratic or Intermittent Display | 1 | Device |
| 2018 | Entrapment of Device | 47 | Device |
| 2018 | Difficult to Remove | 7 | Device |
| 2018 | Difficult to Advance | 1 | Device |
| 2018 | Device Packaging Compromised | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 18 | Device |
| 2018 | Device Damaged by Another Device | 22 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2018 | Detachment of Device or Device Component | 4 | Device |
| 2018 | Detachment Of Device Component | 12 | Device |
| 2018 | Contamination | 1 | Device |
| 2018 | Break | 1 | Device |
| 2018 | Backflow | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2018 | Activation Problem | 2 | Device |
| 2017 | Unsealed Device Packaging | 1 | Device |
| 2017 | Torn Material | 3 | Device |
| 2017 | Thermal Decomposition of Device | 1 | Device |
| 2017 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2017 | Overheating of Device | 1 | Device |
| 2017 | Mechanical Jam | 1 | Device |
| 2017 | Material Rupture | 1 | Device |
| 2017 | Kinked | 1 | Device |
| 2017 | Infusion or Flow Problem | 1 | Device |
| 2017 | Hole In Material | 1 | Device |
| 2017 | Fracture | 2 | Device |
| 2017 | Fluid/Blood Leak | 3 | Device |
| 2017 | Failure to Advance | 5 | Device |
| 2017 | Entrapment of Device | 72 | Device |
| 2017 | Difficult to Remove | 4 | Device |
| 2017 | Difficult to Insert | 1 | Device |
| 2017 | Device Packaging Compromised | 3 | Device |
| 2017 | Device Operates Differently Than Expected | 16 | Device |
| 2017 | Device Damaged by Another Device | 59 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2017 | Detachment of Device or Device Component | 4 | Device |
| 2017 | Detachment Of Device Component | 15 | Device |
| 2017 | Defective Component | 2 | Device |
| 2017 | Decrease in Pressure | 1 | Device |
| 2017 | Contamination | 1 | Device |
| 2017 | Charred | 1 | Device |
| 2017 | Break | 8 | Device |
| 2017 | Air Leak | 3 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
| 2016 | Unintended Movement | 1 | Device |
| 2016 | Overheating of Device | 1 | Device |
| 2016 | Noise, Audible | 1 | Device |
| 2016 | Leak/Splash | 3 | Device |
| 2016 | Hole In Material | 2 | Device |
| 2016 | Fracture | 1 | Device |
| 2016 | Fluid/Blood Leak | 2 | Device |
| 2016 | Failure to Advance | 1 | Device |
| 2016 | Excess Flow or Over-Infusion | 1 | Device |
| 2016 | Entrapment of Device | 42 | Device |
| 2016 | Difficult to Remove | 5 | Device |
| 2016 | Device Operates Differently Than Expected | 8 | Device |
| 2016 | Device Damaged by Another Device | 30 | Device |
| 2016 | Device Damaged Prior to Use | 1 | Device |
| 2016 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2016 | Detachment of Device or Device Component | 2 | Device |
| 2016 | Detachment Of Device Component | 8 | Device |
| 2016 | Defective Component | 2 | Device |
| 2016 | Contamination | 2 | Device |
| 2016 | Break | 3 | Device |
| 2016 | Backflow | 2 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 15 | Device |
| 2015 | Noise, Audible | 1 | Device |
| 2015 | Fluid/Blood Leak | 1 | Device |
| 2015 | Failure to Advance | 1 | Device |
| 2015 | Entrapment of Device | 17 | Device |
| 2015 | Difficult to Remove | 1 | Device |
| 2015 | Difficult to Insert | 2 | Device |
| 2015 | Difficult to Advance | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 3 | Device |
| 2015 | Device Damaged by Another Device | 9 | Device |
| 2015 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2015 | Detachment Of Device Component | 4 | Device |
| 2015 | Defective Component | 1 | Device |
| 2014 | Torn Material | 4 | Device |
| 2014 | Thermal Decomposition of Device | 2 | Device |
| 2014 | Stretched | 1 | Device |
| 2014 | Physical Resistance | 1 | Device |
| 2014 | Overheating of Device | 2 | Device |
| 2014 | Noise, Audible | 1 | Device |
| 2014 | Material Deformation | 1 | Device |
| 2014 | Kinked | 1 | Device |
| 2014 | Hole In Material | 1 | Device |
| 2014 | Fluid/Blood Leak | 5 | Device |
| 2014 | Entrapment of Device | 15 | Device |
| 2014 | Difficult to Remove | 2 | Device |
| 2014 | Device Operates Differently Than Expected | 3 | Device |
| 2014 | Device Damaged by Another Device | 17 | Device |
| 2014 | Device Damaged Prior to Use | 3 | Device |
| 2014 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2014 | Detachment of Device or Device Component | 5 | Device |
| 2014 | Detachment Of Device Component | 2 | Device |
| 2014 | Defective Component | 2 | Device |
| 2014 | Crack | 1 | Device |
| 2014 | Break | 2 | Device |
| 2014 | Air Leak | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2013 | Thermal Decomposition of Device | 1 | Device |
| 2013 | Kinked | 2 | Device |
| 2013 | Difficult to Advance | 1 | Device |
| 2013 | Device Operates Differently Than Expected | 1 | Device |
| 2013 | Device Damaged by Another Device | 5 | Device |
| 2013 | Detachment of Device or Device Component | 1 | Device |
| 2013 | Defective Component | 1 | Device |