Definition: To Provide Circulatory Support For Patients In Cardiogenic Shock Due To Acute Right Ventricular Failure.
| Device Type ID | 1069 |
| Device Name | Right Ventricular Bypass (assist) Device |
| Physical State | The System Is Comprised Of A Blood Pump, Motor, Drive Console, Flow Sensor, And Inlet And Outlet Cannulae. The Blood Pump Is Single-use Only But The Other Components Can Be Reused. |
| Technical Method | The Blood Pump Is Driven By A Motor And Controller, To Propel Blood From The Right Ventricle Or Atrium To The Pulmonary Circulation. |
| Target Area | Right Ventricle Or Atrium To Pulmonary Circulation |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | OJE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1069 |
| Device | Right Ventricular Bypass (assist) Device |
| Product Code | OJE |
| Device Problems | |
|---|---|
Difficult To Position | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Positioning Problem | 2 |
Material Separation | 2 |
Device Issue | 2 |
Device Handling Problem | 1 |
Detachment Of Device Component | 1 |
Difficult To Advance | 1 |
Material Perforation | 1 |
Break | 1 |
Appropriate Term/Code Not Available | 1 |
Material Integrity Problem | 1 |
Difficult To Remove | 1 |
Physical Resistance | 1 |
Patient-Device Incompatibility | 1 |
Device Operational Issue | 1 |
Human-Device Interface Problem | 1 |
Infusion Or Flow Problem | 1 |
| Total Device Problems | 25 |