CATHETER, CORONARY, ATHERECTOMY
This device is manufactured by BOSTON SCIENTIFIC - COSTA RICA (COYOL).
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2018 | Physical Resistance | 1 | Device |
| 2018 | Material Separation | 1 | Device |
| 2018 | Fracture | 8 | Device |
| 2018 | Entrapment of Device | 16 | Device |
| 2018 | Difficult to Remove | 2 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2018 | Detachment Of Device Component | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2017 | Fracture | 23 | Device |
| 2017 | Failure to Advance | 1 | Device |
| 2017 | Entrapment of Device | 26 | Device |
| 2017 | Difficult to Remove | 1 | Device |
| 2017 | Difficult to Insert | 1 | Device |
| 2017 | Detachment of Device or Device Component | 3 | Device |
| 2017 | Detachment Of Device Component | 2 | Device |
| 2017 | Charred | 1 | Device |
| 2017 | Break | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
| 2016 | Material Discolored | 1 | Device |
| 2016 | Fracture | 12 | Device |
| 2016 | Entrapment of Device | 20 | Device |
| 2016 | Detachment Of Device Component | 5 | Device |
| 2016 | Delivered as Unsterile Product | 1 | Device |
| 2016 | Degraded | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2015 | Physical Resistance | 1 | Device |
| 2015 | Kinked | 1 | Device |
| 2015 | Fracture | 6 | Device |
| 2015 | Entrapment of Device | 6 | Device |
| 2015 | Detachment Of Device Component | 3 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2014 | Physical Resistance | 1 | Device |
| 2014 | Material Separation | 1 | Device |
| 2014 | Kinked | 2 | Device |
| 2014 | Fracture | 17 | Device |
| 2014 | Entrapment of Device | 1 | Device |
| 2014 | Device Damaged Prior to Use | 1 | Device |
| 2014 | Detachment of Device or Device Component | 1 | Device |
| 2014 | Detachment Of Device Component | 2 | Device |
| 2014 | Break | 2 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2013 | Kinked | 1 | Device |
| 2013 | Fracture | 3 | Device |
| 2013 | Entrapment of Device | 1 | Device |
| 2013 | Difficult to Advance | 2 | Device |
| 2013 | Detachment of Device or Device Component | 2 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2011 | Adverse Event Without Identified Device or Use Problem | 1 | Device |