| Device Type ID | 1025 |
| Device Name | Catheter, Coronary, Atherectomy |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MCX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1025 |
| Device | Catheter, Coronary, Atherectomy |
| Product Code | MCX |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Entrapment Of Device | 648 |
Adverse Event Without Identified Device Or Use Problem | 571 |
Guidewire | 517 |
Catheter | 404 |
Fracture | 288 |
Device Damaged By Another Device | 277 |
Detachment Of Device Component | 147 |
Device Operates Differently Than Expected | 139 |
No Display / Image | 91 |
Material Separation | 91 |
Tip | 86 |
Detachment Of Device Or Device Component | 76 |
Display | 74 |
Difficult To Remove | 65 |
Device Displays Incorrect Message | 45 |
Shaft | 44 |
Aspiration Issue | 44 |
Device Contamination With Chemical Or Other Material | 34 |
Break | 34 |
Kinked | 30 |
Brake | 29 |
Failure To Advance | 28 |
Fluid Leak | 27 |
Foot Pedal | 25 |
Sticking | 22 |
Mechanical Problem | 21 |
Output Problem | 21 |
Device Damaged Prior To Use | 19 |
Unintended System Motion | 14 |
Unstable | 13 |
Defective Component | 12 |
Torn Material | 12 |
Material Deformation | 12 |
Generator | 12 |
Noise, Audible | 11 |
Defective Device | 11 |
Display Or Visual Feedback Problem | 10 |
Difficult To Advance | 10 |
Hole In Material | 9 |
Leak / Splash | 8 |
Material Rupture | 7 |
Difficult To Insert | 6 |
Physical Resistance / Sticking | 6 |
Intermittent Loss Of Power | 6 |
Contamination During Use | 6 |
Material Split, Cut Or Torn | 5 |
Suction Problem | 5 |
Device Packaging Compromised | 5 |
Stretched | 5 |
Unexpected Shutdown | 4 |
Unsealed Device Packaging | 4 |
Air Leak | 4 |
Backflow | 4 |
Material Integrity Problem | 4 |
Physical Resistance | 4 |
Foot Switch | 4 |
Infusion Or Flow Problem | 4 |
Gas Leak | 3 |
Power Problem | 3 |
Activation Problem | 3 |
Material Fragmentation | 3 |
Unintended Movement | 3 |
Knob | 3 |
Overheating Of Device | 3 |
Thermal Decomposition Of Device | 3 |
Failure To Disconnect | 3 |
Positioning Problem | 2 |
Charred | 2 |
Failure To Power Up | 2 |
Failure To Deliver | 2 |
Use Of Device Problem | 2 |
Delivered As Unsterile Product | 2 |
Wire | 2 |
Unraveled Material | 2 |
Device Stops Intermittently | 2 |
Material Discolored | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Sparking | 1 |
Device Operational Issue | 1 |
Bent | 1 |
Migration Or Expulsion Of Device | 1 |
Failure To Prime | 1 |
Connection Problem | 1 |
Inappropriate Or Unexpected Reset | 1 |
Output Above Specifications | 1 |
Device Remains Activated | 1 |
Occlusion Within Device | 1 |
Degraded | 1 |
Melted | 1 |
Obstruction Of Flow | 1 |
Device Dislodged Or Dislocated | 1 |
Tube | 1 |
Positioning Failure | 1 |
Loss Of Power | 1 |
Excess Flow Or Over-Infusion | 1 |
Device Issue | 1 |
Mechanical Jam | 1 |
Pumping Problem | 1 |
Device-Device Incompatibility | 1 |
Decrease In Pressure | 1 |
| Total Device Problems | 4184 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corporation | II | Mar-03-2017 |
| 2 | Boston Scientific Corporation | I | Nov-13-2015 |
| 3 | Cardiovascular Systems Inc | II | Sep-11-2018 |
| 4 | Cardiovascular Systems Inc | II | May-20-2017 |
| 5 | Cardiovascular Systems, Inc. | I | Mar-20-2015 |
| 6 | Cardiovascular Systems, Inc. | III | Feb-26-2014 |