PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
This device is manufactured by MEDTRONIC CRYOCATH LP.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Thromboembolism | 1 | Patient |
| 2024 | Pericardial Effusion | 1 | Patient |
| 2024 | Non specific EKG/ECG Changes | 1 | Patient |
| 2024 | Nerve Damage | 2 | Patient |
| 2024 | Inflammation | 1 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Cardiac Tamponade | 1 | Patient |
| 2024 | Cardiac Perforation | 1 | Patient |
| 2024 | Atrial Fibrillation | 1 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Use of Device Problem | 3 | Device |
| 2024 | Temperature Problem | 3 | Device |
| 2024 | Protective Measures Problem | 11 | Device |
| 2024 | Mechanical Problem | 1 | Device |
| 2024 | Material Twisted/Bent | 11 | Device |
| 2024 | Material Integrity Problem | 7 | Device |
| 2024 | Material Deformation | 1 | Device |
| 2024 | Leak/Splash | 5 | Device |
| 2024 | Insufficient Information | 2 | Device |
| 2024 | Infusion or Flow Problem | 3 | Device |
| 2024 | Gas/Air Leak | 6 | Device |
| 2024 | Excessive Cooling | 5 | Device |
| 2024 | Device Contamination with Body Fluid | 5 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2023 | Tricuspid Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2023 | Transient Ischemic Attack | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Pseudoaneurysm | 1 | Patient |
| 2023 | Pericardial Effusion | 3 | Patient |
| 2023 | Paresis | 1 | Patient |
| 2023 | Nerve Damage | 5 | Patient |
| 2023 | Mitral Valve Insufficiency/ Regurgitation | 2 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hypoxia | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2023 | Embolism/Embolus | 1 | Patient |
| 2023 | Cardiac Tamponade | 4 | Patient |
| 2023 | Bradycardia | 1 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Protective Measures Problem | 4 | Device |
| 2023 | Off-Label Use | 1 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Material Twisted/Bent | 2 | Device |
| 2023 | Material Integrity Problem | 3 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Leak/Splash | 1 | Device |
| 2023 | Insufficient Information | 3 | Device |
| 2023 | Infusion or Flow Problem | 3 | Device |
| 2023 | Excessive Cooling | 8 | Device |
| 2023 | Device Handling Problem | 1 | Device |
| 2023 | Compatibility Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 17 | Device |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Use of Device Problem | 3 | Device |
| 2022 | Protective Measures Problem | 2 | Device |
| 2022 | Material Twisted/Bent | 5 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Device Handling Problem | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |