DCB PTA CATHETER
This device is manufactured by SPECTRANETICS.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Material Rupture | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 201 | Device |
| 2018 | Occlusion Within Device | 2 | Device |
| 2018 | Insufficient Information | 3 | Device |
| 2018 | Difficult to Remove | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 3 | Device |
| 2018 | Device Markings/Labelling Problem | 1 | Device |
| 2018 | Deflation Problem | 2 | Device |
| 2018 | Burst Container or Vessel | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 320 | Device |
| 2017 | Occlusion Within Device | 22 | Device |
| 2017 | Insufficient Information | 13 | Device |
| 2017 | Inflation Problem | 2 | Device |
| 2017 | Improper or Incorrect Procedure or Method | 2 | Device |
| 2017 | Improper Flow or Infusion | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 7 | Device |
| 2017 | Deflation Problem | 1 | Device |
| 2017 | Appropriate Term/Code Not Available | 3 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 125 | Device |
| 2016 | Insufficient Information | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 24 | Device |
| 2015 | Insufficient Information | 3 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 35 | Device |
| 2014 | Insufficient Information | 2 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
| 2013 | Insufficient Information | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 12 | Device |