CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Rupture | 67 | Device |
| 2024 | Material Deformation | 1 | Device |
| 2024 | Inflation Problem | 1 | Device |
| 2024 | Difficult to Remove | 1 | Device |
| 2024 | Detachment of Device or Device Component | 1 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Foreign Body In Patient | 1 | Patient |
| 2023 | Poor Visibility | 1 | Device |
| 2023 | Material Rupture | 100 | Device |
| 2023 | Failure to Advance | 3 | Device |
| 2023 | Difficult to Remove | 3 | Device |
| 2023 | Difficult to Advance | 2 | Device |
| 2023 | Device-Device Incompatibility | 1 | Device |
| 2023 | Detachment of Device or Device Component | 3 | Device |
| 2023 | Break | 4 | Device |
| 2022 | Material Rupture | 93 | Device |
| 2022 | Material Integrity Problem | 2 | Device |
| 2022 | Leak/Splash | 2 | Device |
| 2022 | Failure to Deflate | 1 | Device |
| 2022 | Entrapment of Device | 5 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Detachment of Device or Device Component | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |