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 | 16 | Device |
| 2024 | Material Puncture/Hole | 1 | Device |
| 2024 | Material Integrity Problem | 1 | Device |
| 2024 | Entrapment of Device | 3 | Device |
| 2024 | Difficult to Advance | 1 | Device |
| 2024 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Material Rupture | 21 | Device |
| 2023 | Leak/Splash | 3 | Device |
| 2023 | Failure to Deflate | 6 | Device |
| 2023 | Entrapment of Device | 1 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2023 | Break | 2 | Device |
| 2022 | Material Rupture | 26 | Device |
| 2022 | Leak/Splash | 1 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Physical Resistance/Sticking | 1 | Device |
| 2019 | Material Rupture | 95 | Device |
| 2019 | Material Integrity Problem | 1 | Device |
| 2019 | Material Deformation | 1 | Device |
| 2019 | Inflation Problem | 1 | Device |
| 2019 | Failure to Advance | 1 | Device |
| 2019 | Entrapment of Device | 11 | Device |
| 2019 | Difficult to Remove | 2 | Device |
| 2019 | Difficult to Advance | 1 | Device |
| 2019 | Detachment of Device or Device Component | 1 | Device |
| 2019 | Deflation Problem | 4 | Device |
| 2019 | Break | 3 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2018 | Unsealed Device Packaging | 1 | Device |
| 2018 | Torn Material | 1 | Device |
| 2018 | Material Rupture | 97 | Device |
| 2018 | Material Puncture/Hole | 1 | Device |
| 2018 | Material Integrity Problem | 2 | Device |
| 2018 | Material Deformation | 2 | Device |
| 2018 | Inflation Problem | 1 | Device |
| 2018 | Incorrect Device Or Component Shipped | 1 | Device |
| 2018 | Fitting Problem | 1 | Device |
| 2018 | Failure to Advance | 3 | Device |
| 2018 | Entrapment of Device | 10 | Device |
| 2018 | Difficult to Remove | 3 | Device |
| 2018 | Difficult to Advance | 2 | Device |
| 2018 | Device-Device Incompatibility | 1 | Device |
| 2018 | Device Damaged Prior to Use | 1 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2018 | Detachment Of Device Component | 1 | Device |
| 2018 | Defective Device | 1 | Device |
| 2018 | Contamination | 1 | Device |
| 2018 | Break | 4 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2017 | Material Twisted/Bent | 1 | Device |
| 2017 | Material Rupture | 88 | Device |
| 2017 | Leak/Splash | 1 | Device |
| 2017 | Inflation Problem | 1 | Device |
| 2017 | Inappropriate or Unexpected Reset | 1 | Device |
| 2017 | Failure to Advance | 4 | Device |
| 2017 | Entrapment of Device | 12 | Device |
| 2017 | Difficult to Remove | 3 | Device |
| 2017 | Device Packaging Compromised | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 2 | Device |
| 2017 | Device Damaged Prior to Use | 1 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2017 | Detachment Of Device Component | 3 | Device |
| 2017 | Break | 5 | Device |
| 2017 | Bent | 1 | Device |
| 2016 | Material Rupture | 34 | Device |
| 2016 | Kinked | 1 | Device |
| 2016 | Hole In Material | 1 | Device |
| 2016 | Entrapment of Device | 3 | Device |
| 2016 | Difficult to Remove | 1 | Device |
| 2016 | Device Markings/Labelling Problem | 1 | Device |
| 2015 | Material Rupture | 11 | Device |
| 2015 | Material Deformation | 1 | Device |
| 2015 | Entrapment of Device | 1 | Device |
| 2014 | Material Rupture | 37 | Device |
| 2014 | Leak/Splash | 1 | Device |
| 2014 | Inflation Problem | 1 | Device |
| 2014 | Entrapment of Device | 5 | Device |
| 2014 | Difficult to Remove | 1 | Device |
| 2014 | Difficult to Advance | 1 | Device |
| 2014 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2014 | Break | 3 | Device |
| 2014 | Bent | 1 | Device |
| 2013 | Material Rupture | 4 | Device |