Definition: For The Treatment Of Atrial Fibrillation.
| Device Type ID | 1063 |
| Device Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Physical State | The Device Is An Ablation Catheter That Features Electrodes Through Which Thermal Energy Is Delivered. |
| Technical Method | The Ablation Catheter Delivers Energy To The Specific Region Of The Heart In Order To Create Lesions That Will Treat The Patient Of Atrial Fibrillation. |
| Target Area | Heart |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Electrophysiology Devices Branch (CEDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OAE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1063 |
| Device | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Product Code | OAE |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 745 |
Material Integrity Problem | 139 |
Fluid Leak | 136 |
Appropriate Term/Code Not Available | 123 |
Material Twisted / Bent | 108 |
Kinked | 98 |
Air Leak | 58 |
Material Deformation | 53 |
Insufficient Information | 38 |
Device Contamination With Body Fluid | 38 |
Break | 37 |
Communication Or Transmission Problem | 23 |
Gas Leak | 18 |
Device Operates Differently Than Expected | 16 |
Optical Problem | 14 |
Catheter | 12 |
Device Displays Incorrect Message | 10 |
Leak / Splash | 9 |
Temperature Problem | 7 |
Improper Or Incorrect Procedure Or Method | 7 |
No Apparent Adverse Event | 6 |
Use Of Device Problem | 6 |
Impedance Problem | 5 |
Device Contamination With Chemical Or Other Material | 5 |
Positioning Problem | 4 |
Suction Problem | 4 |
No Display / Image | 4 |
High Impedance | 4 |
Balloon | 3 |
Signal Artifact | 3 |
Difficult To Advance | 3 |
Material Rupture | 2 |
Display Or Visual Feedback Problem | 2 |
Partial Blockage | 2 |
Aspiration Issue | 2 |
Failure To Deliver Energy | 2 |
Obstruction Of Flow | 2 |
Deformation Due To Compressive Stress | 2 |
Delivered As Unsterile Product | 2 |
Occlusion Within Device | 2 |
Cable | 2 |
Fracture | 1 |
Difficult To Remove | 1 |
Application Program Version Or Upgrade Problem | 1 |
Device Operational Issue | 1 |
Human-Device Interface Problem | 1 |
Infusion Or Flow Problem | 1 |
Low Impedance | 1 |
Water Purification System | 1 |
Data Problem | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Failure To Advance | 1 |
Device Sensing Problem | 1 |
Guidewire | 1 |
Contamination During Use | 1 |
Energy Output Problem | 1 |
Product Quality Problem | 1 |
Failure To Read Input Signal | 1 |
Electrical /Electronic Property Problem | 1 |
Material Frayed | 1 |
Deflation Problem | 1 |
Electrode | 1 |
Luer Valve | 1 |
Retraction Problem | 1 |
Material Split, Cut Or Torn | 1 |
Off-Label Use | 1 |
Material Too Rigid Or Stiff | 1 |
Material Separation | 1 |
Protective Measures Problem | 1 |
Pressure Problem | 1 |
Peeled / Delaminated | 1 |
Decrease In Pressure | 1 |
Sticking | 1 |
Crack | 1 |
Nonstandard Device | 1 |
Difficult To Position | 1 |
Improper Flow Or Infusion | 1 |
Packaging Problem | 1 |
Ambient Noise Problem | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Connector | 1 |
Disconnection | 1 |
Restricted Flow Rate | 1 |
| Total Device Problems | 1799 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biosense Webster, Inc. | II | May-28-2015 |
| 2 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | III | Mar-28-2019 |
| 3 | St Jude Medical | II | Mar-17-2015 |