Definition: For The Treatment Of Atrial Flutter.
| Device Type ID | 1062 |
| Device Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| 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 Flutter. |
| 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 | OAD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1062 |
| Device | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Product Code | OAD |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 434 |
Catheter | 86 |
Break | 60 |
Device Operates Differently Than Expected | 58 |
Steering Wire | 43 |
Kinked | 31 |
Tip | 28 |
Device Remains Activated | 26 |
Bent | 22 |
Temperature Problem | 20 |
Device Sensing Problem | 19 |
Shaft | 18 |
Device Displays Incorrect Message | 16 |
Signal Artifact | 15 |
Fluid Leak | 10 |
Impedance Problem | 9 |
Communication Or Transmission Problem | 8 |
Fracture | 7 |
Data Problem | 7 |
Appropriate Term/Code Not Available | 7 |
Foot Pedal | 7 |
Tear, Rip Or Hole In Device Packaging | 6 |
Material Integrity Problem | 6 |
Failure To Sense | 6 |
Material Separation | 6 |
Failure To Deliver Energy | 5 |
Device Contamination With Chemical Or Other Material | 5 |
Leak / Splash | 5 |
Positioning Problem | 5 |
Charred | 5 |
Crack | 5 |
Foot Switch | 5 |
Difficult To Remove | 5 |
Electrical /Electronic Property Problem | 5 |
Electrode | 5 |
Occlusion Within Device | 4 |
Inadequate Storage | 4 |
Insufficient Information | 4 |
Detachment Of Device Or Device Component | 3 |
Improper Flow Or Infusion | 3 |
No Device Output | 3 |
Cut In Material | 3 |
Mechanics Altered | 3 |
Poor Quality Image | 3 |
Hole In Material | 3 |
Generator | 3 |
Material Frayed | 3 |
No Display / Image | 3 |
Material Puncture / Hole | 3 |
Material Discolored | 3 |
Contamination During Use | 2 |
Use Of Device Problem | 2 |
Wire | 2 |
High Impedance | 2 |
Unsealed Device Packaging | 2 |
Failure To Power Up | 2 |
Device Damaged By Another Device | 2 |
Device Packaging Compromised | 2 |
Detachment Of Device Component | 2 |
Material Deformation | 2 |
Pressure Problem | 2 |
Insufficient Flow Or Under Infusion | 2 |
Device Damaged Prior To Use | 2 |
Entrapment Of Device | 2 |
Overheating Of Device | 2 |
Noise, Audible | 2 |
Mechanical Problem | 2 |
Difficult To Position | 1 |
Defective Device | 1 |
Torn Material | 1 |
Display Or Visual Feedback Problem | 1 |
Flushing Problem | 1 |
Controller | 1 |
Probe | 1 |
Temperature Sensor | 1 |
Failure To Disconnect | 1 |
Loose Or Intermittent Connection | 1 |
Housing | 1 |
Device Alarm System | 1 |
Unintended Movement | 1 |
Material Protrusion / Extrusion | 1 |
Mechanical Jam | 1 |
Pumping Problem | 1 |
Material Too Rigid Or Stiff | 1 |
Ring | 1 |
Air Leak | 1 |
Device Issue | 1 |
Delivered As Unsterile Product | 1 |
Insufficient Heating | 1 |
No Pacing | 1 |
Obstruction Of Flow | 1 |
Deformation Due To Compressive Stress | 1 |
Failure To Auto Stop | 1 |
Physical Property Issue | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Pressure Sensor | 1 |
Degraded | 1 |
Smoking | 1 |
Seal | 1 |
Corroded | 1 |
| Total Device Problems | 1120 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corp | II | Dec-22-2015 |
| 2 | Boston Scientific Corp | I | Mar-02-2015 |
| 3 | Boston Scientific Corporation | III | Jan-08-2019 |
| 4 | Boston Scientific Corporation | II | Aug-28-2018 |
| 5 | Boston Scientific Corporation | II | Jun-16-2014 |