CORONARY ATHERECTOMY DEVICE
This device is manufactured by CARDIOVASCULAR SYSTEMS, CARDIOVASCULAR SYSTEMS (ABBOTT), CARDIOVASCULAR SYSTEMS ORPORATED.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Vascular Dissection | 5 | Patient |
| 2024 | Reduced Blood Flow | 2 | Patient |
| 2024 | Pericardial Effusion | 1 | Patient |
| 2024 | Perforation of Vessels | 8 | Patient |
| 2024 | Myocardial Infarction | 1 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 3 | Patient |
| 2024 | Hematoma | 1 | Patient |
| 2024 | Foreign Body In Patient | 5 | Patient |
| 2024 | Device Embedded In Tissue or Plaque | 5 | Patient |
| 2024 | Cardiac Tamponade | 2 | Patient |
| 2024 | Cardiac Arrest | 3 | Patient |
| 2024 | Unintended System Motion | 2 | Device |
| 2024 | Unexpected Shutdown | 1 | Device |
| 2024 | Material Separation | 6 | Device |
| 2024 | Entrapment of Device | 5 | Device |
| 2024 | Difficult to Advance | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Vasoconstriction | 1 | Patient |
| 2023 | Vascular Dissection | 11 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Stroke/CVA | 1 | Patient |
| 2023 | Pericardial Effusion | 3 | Patient |
| 2023 | Perforation of Vessels | 17 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2023 | Foreign Body In Patient | 18 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2023 | Chest Pain | 3 | Patient |
| 2023 | Cardiovascular Insufficiency | 1 | Patient |
| 2023 | Bradycardia | 2 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 5 | Patient |
| 2023 | Use of Device Problem | 2 | Device |
| 2023 | Unintended System Motion | 4 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Material Separation | 22 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2023 | Fracture | 2 | Device |
| 2023 | Failure to Advance | 1 | Device |
| 2023 | Entrapment of Device | 4 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 22 | Device |
| 2022 | Perforation of Vessels | 1 | Patient |
| 2022 | Foreign Body In Patient | 2 | Patient |
| 2022 | Unintended System Motion | 2 | Device |
| 2022 | Unintended Movement | 1 | Device |
| 2022 | Product Quality Problem | 1 | Device |
| 2022 | Overheating of Device | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Material Separation | 22 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Material Deformation | 2 | Device |
| 2022 | Intermittent Loss of Power | 1 | Device |
| 2022 | Infusion or Flow Problem | 2 | Device |
| 2022 | Entrapment of Device | 2 | Device |
| 2022 | Device Markings/Labelling Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 13 | Device |
| 2020 | Vascular Dissection | 1 | Patient |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Thrombosis/Thrombus | 1 | Patient |
| 2019 | Myocardial Infarction | 5 | Patient |
| 2019 | Unintended System Motion | 7 | Device |
| 2019 | Unexpected Shutdown | 1 | Device |
| 2019 | Stretched | 1 | Device |
| 2019 | Positioning Problem | 3 | Device |
| 2019 | Positioning Failure | 1 | Device |
| 2019 | Off-Label Use | 2 | Device |
| 2019 | Noise, Audible | 3 | Device |
| 2019 | Migration | 1 | Device |
| 2019 | Mechanical Jam | 1 | Device |
| 2019 | Material Separation | 36 | Device |
| 2019 | Insufficient Flow or Under Infusion | 1 | Device |
| 2019 | Improper Flow or Infusion | 1 | Device |
| 2019 | Failure to Advance | 1 | Device |
| 2019 | Excess Flow or Over-Infusion | 1 | Device |
| 2019 | Entrapment of Device | 19 | Device |
| 2019 | Electrical /Electronic Property Problem | 1 | Device |
| 2019 | Device Remains Activated | 1 | Device |
| 2019 | Device Dislodged or Dislocated | 2 | Device |
| 2019 | Device Damaged by Another Device | 2 | Device |
| 2019 | Break | 3 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 55 | Device |
| 2019 | Activation Failure | 1 | Device |
| 2018 | Vascular Dissection | 2 | Patient |
| 2018 | Myocardial Infarction | 7 | Patient |
| 2018 | Appropriate Term / Code Not Available | 3 | Patient |
| 2018 | Unraveled Material | 1 | Device |
| 2018 | Unintended System Motion | 15 | Device |
| 2018 | Unexpected Shutdown | 2 | Device |
| 2018 | Protective Measures Problem | 1 | Device |
| 2018 | Positioning Problem | 2 | Device |
| 2018 | Positioning Failure | 1 | Device |
| 2018 | Peeled/Delaminated | 1 | Device |
| 2018 | Obstruction of Flow | 1 | Device |
| 2018 | Noise, Audible | 5 | Device |
| 2018 | Migration or Expulsion of Device | 1 | Device |
| 2018 | Mechanical Problem | 3 | Device |
| 2018 | Material Separation | 50 | Device |
| 2018 | Loose or Intermittent Connection | 1 | Device |
| 2018 | Intermittent Loss of Power | 1 | Device |
| 2018 | Infusion or Flow Problem | 1 | Device |
| 2018 | Improper Flow or Infusion | 1 | Device |
| 2018 | Fracture | 2 | Device |
| 2018 | Failure to Power Up | 3 | Device |
| 2018 | Failure to Advance | 1 | Device |
| 2018 | Entrapment of Device | 16 | Device |
| 2018 | Difficult to Remove | 3 | Device |
| 2018 | Difficult to Advance | 2 | Device |
| 2018 | Device Operational Issue | 1 | Device |
| 2018 | Device Damaged by Another Device | 1 | Device |
| 2018 | Detachment of Device or Device Component | 22 | Device |
| 2018 | Detachment Of Device Component | 2 | Device |
| 2018 | Complete Loss of Power | 1 | Device |
| 2018 | Break | 6 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Air Leak | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 154 | Device |
| 2017 | Myocardial Infarction | 5 | Patient |
| 2017 | Sticking | 1 | Device |
| 2017 | Pumping Problem | 1 | Device |
| 2017 | Material Separation | 18 | Device |
| 2017 | Material Fragmentation | 1 | Device |
| 2017 | Fracture | 1 | Device |
| 2017 | Entrapment of Device | 2 | Device |
| 2017 | Difficult to Remove | 4 | Device |
| 2017 | Device Operates Differently Than Expected | 8 | Device |
| 2017 | Device Issue | 1 | Device |
| 2017 | Detachment Of Device Component | 3 | Device |
| 2017 | Defective Alarm | 1 | Device |
| 2017 | Component Falling | 1 | Device |
| 2017 | Break | 4 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 91 | Device |
| 2016 | Material Separation | 8 | Device |
| 2016 | Insufficient Information | 1 | Device |
| 2016 | Fracture | 1 | Device |
| 2016 | Failure to Deliver | 2 | Device |
| 2016 | Entrapment of Device | 4 | Device |
| 2016 | Difficult to Remove | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 3 | Device |
| 2016 | Device Dislodged or Dislocated | 1 | Device |
| 2016 | Detachment Of Device Component | 3 | Device |
| 2016 | Break | 3 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 33 | Device |
| 2015 | No Flow | 2 | Device |
| 2015 | Insufficient Information | 2 | Device |
| 2015 | Difficult to Advance | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2014 | Unintended Movement | 1 | Device |
| 2014 | Migration or Expulsion of Device | 1 | Device |
| 2014 | Insufficient Information | 3 | Device |
| 2014 | Infusion or Flow Problem | 1 | Device |
| 2014 | Fracture | 1 | Device |
| 2014 | Failure to Advance | 1 | Device |
| 2014 | Difficult to Advance | 1 | Device |
| 2014 | Difficult or Delayed Positioning | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 2 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2013 | Insufficient Flow or Under Infusion | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 1 | Device |