CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
This device is manufactured by BOSTON SCIENTIFIC CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Foreign Body In Patient | 1 | Patient |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Material Rupture | 23 | Device |
| 2024 | Failure to Advance | 1 | Device |
| 2024 | Difficult to Remove | 1 | Device |
| 2024 | Break | 3 | Device |
| 2023 | Poor Visibility | 1 | Device |
| 2023 | Material Rupture | 5 | Device |
| 2023 | Inflation Problem | 1 | Device |
| 2023 | Failure to Advance | 4 | Device |
| 2023 | Break | 2 | Device |
| 2022 | Material Rupture | 7 | Device |
| 2022 | Material Deformation | 2 | Device |
| 2022 | Leak/Splash | 1 | Device |
| 2022 | Inflation Problem | 1 | Device |
| 2022 | Failure to Advance | 1 | Device |
| 2022 | Difficult to Advance | 2 | Device |
| 2022 | Break | 4 | Device |
| 2019 | Material Rupture | 18 | Device |
| 2019 | Material Deformation | 5 | Device |
| 2019 | Inflation Problem | 2 | Device |
| 2019 | Failure to Advance | 15 | Device |
| 2019 | Difficult to Advance | 2 | Device |
| 2019 | Break | 29 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2018 | Unsealed Device Packaging | 2 | Device |
| 2018 | Material Separation | 1 | Device |
| 2018 | Material Rupture | 48 | Device |
| 2018 | Material Puncture/Hole | 1 | Device |
| 2018 | Material Deformation | 3 | Device |
| 2018 | Leak/Splash | 1 | Device |
| 2018 | Kinked | 2 | Device |
| 2018 | Inflation Problem | 4 | Device |
| 2018 | Hole In Material | 1 | Device |
| 2018 | Failure to Advance | 33 | Device |
| 2018 | Difficult to Remove | 1 | Device |
| 2018 | Difficult to Advance | 1 | Device |
| 2018 | Device Damaged Prior to Use | 4 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2018 | Break | 38 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2017 | Torn Material | 1 | Device |
| 2017 | Material Rupture | 32 | Device |
| 2017 | Material Deformation | 1 | Device |
| 2017 | Leak/Splash | 3 | Device |
| 2017 | Kinked | 2 | Device |
| 2017 | Inflation Problem | 5 | Device |
| 2017 | Failure to Advance | 23 | Device |
| 2017 | Difficult to Remove | 1 | Device |
| 2017 | Device Damaged Prior to Use | 2 | Device |
| 2017 | Detachment of Device or Device Component | 1 | Device |
| 2017 | Detachment Of Device Component | 1 | Device |
| 2017 | Deflation Problem | 1 | Device |
| 2017 | Break | 24 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2016 | Torn Material | 1 | Device |
| 2016 | Material Rupture | 15 | Device |
| 2016 | Leak/Splash | 2 | Device |
| 2016 | Kinked | 7 | Device |
| 2016 | Inflation Problem | 3 | Device |
| 2016 | Failure to Advance | 9 | Device |
| 2016 | Difficult to Remove | 2 | Device |
| 2016 | Device Damaged Prior to Use | 2 | Device |
| 2016 | Detachment Of Device Component | 1 | Device |
| 2016 | Break | 11 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2015 | Partial Blockage | 1 | Device |
| 2015 | Material Rupture | 3 | Device |
| 2015 | Failure to Advance | 4 | Device |
| 2015 | Break | 3 | Device |
| 2014 | Material Rupture | 19 | Device |
| 2014 | Material Integrity Problem | 1 | Device |
| 2014 | Kinked | 1 | Device |
| 2014 | Inflation Problem | 1 | Device |
| 2014 | Failure to Advance | 7 | Device |
| 2014 | Device Damaged Prior to Use | 1 | Device |
| 2014 | Detachment of Device or Device Component | 1 | Device |
| 2014 | Break | 14 | Device |
| 2013 | Material Rupture | 4 | Device |
| 2013 | Kinked | 1 | Device |
| 2013 | Failure to Advance | 1 | Device |
| 2013 | Entrapment of Device | 1 | Device |
| 2013 | Detachment Of Device Component | 1 | Device |
| 2013 | Break | 2 | Device |