Definition: A Blood Pump That Provides Temporary Full Or Partial Left Heart Support
| Device Type ID | 1073 |
| Device Name | Temporary Non-roller Type Left Heart Support Blood Pump |
| Physical State | Rotor Or Axial Type Pump Manufactured Of Various Materials. Single Use, Disposable. |
| Technical Method | Pumps Part Or All Of The Patient's Blood Circulation Either During An Adjunctive Procedure Where The Patient Requires Hemodynamic Stability, Or A Temporary Use Of The Device To Unload The Heart To Give It Time To Recover From An Acute Condition. |
| Target Area | Heart |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OZD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1073 |
| Device | Temporary Non-roller Type Left Heart Support Blood Pump |
| Product Code | OZD |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 92 |
Patient-Device Incompatibility | 32 |
Human-Device Interface Problem | 23 |
Positioning Problem | 21 |
Malposition Of Device | 19 |
Insufficient Information | 18 |
Patient Device Interaction Problem | 17 |
Kinked | 16 |
Appropriate Term/Code Not Available | 16 |
Device Operates Differently Than Expected | 14 |
Difficult To Remove | 14 |
Device-Device Incompatibility | 13 |
Difficult To Position | 10 |
Device Issue | 9 |
Material Separation | 8 |
Device Handling Problem | 8 |
Use Of Device Problem | 8 |
Fracture | 7 |
Missing Value Reason | 6 |
Break | 6 |
Difficult To Insert | 6 |
Activation, Positioning Or Separation Problem | 5 |
Difficult Or Delayed Positioning | 5 |
Improper Or Incorrect Procedure Or Method | 4 |
Entrapment Of Device | 4 |
Pumping Stopped | 4 |
Torn Material | 4 |
Material Deformation | 4 |
Inadequacy Of Device Shape And/or Size | 3 |
Crack | 3 |
Difficult To Advance | 3 |
Compatibility Problem | 3 |
Material Integrity Problem | 3 |
Physical Resistance | 3 |
No Apparent Adverse Event | 3 |
Suction Problem | 3 |
Deformation Due To Compressive Stress | 2 |
Retraction Problem | 2 |
Physical Property Issue | 2 |
Material Frayed | 2 |
Device Operational Issue | 2 |
Infusion Or Flow Problem | 2 |
Detachment Of Device Or Device Component | 2 |
Unintended Movement | 2 |
Off-Label Use | 2 |
Human Factors Issue | 1 |
Physical Resistance / Sticking | 1 |
Detachment Of Device Component | 1 |
Difficult To Fold Or Unfold | 1 |
Output Problem | 1 |
Fluid Leak | 1 |
Material Rupture | 1 |
Restricted Flow Rate | 1 |
Disconnection | 1 |
Material Twisted / Bent | 1 |
Bent | 1 |
Migration | 1 |
Device Stops Intermittently | 1 |
Device Inoperable | 1 |
Coiled | 1 |
Device Dislodged Or Dislocated | 1 |
Loss Of Or Failure To Bond | 1 |
| Total Device Problems | 452 |