Definition: Approved Pma: P870072
| Device Type ID | 1004 |
| Device Name | Ventricular (assist) Bypass |
| 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 | DSQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1004 |
| Device | Ventricular (assist) Bypass |
| Product Code | DSQ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 16755 |
Battery Problem | 4199 |
Power Problem | 2788 |
Connection Problem | 2602 |
Pumping Problem | 2558 |
Break | 2233 |
Device Stops Intermittently | 2134 |
Infusion Or Flow Problem | 1800 |
Loose Or Intermittent Connection | 1276 |
High Readings | 1222 |
Material Integrity Problem | 1033 |
Pumping Stopped | 1026 |
Obstruction Of Flow | 973 |
Decreased Pump Speed | 625 |
Controller | 620 |
Material Deformation | 449 |
Pump | 438 |
Device Displays Incorrect Message | 426 |
Insufficient Information | 392 |
Disconnection | 357 |
Electrical Shorting | 346 |
Use Of Device Problem | 336 |
Battery | 324 |
Device Contamination With Chemical Or Other Material | 322 |
Device Alarm System | 307 |
Partial Blockage | 256 |
No Audible Alarm | 246 |
Device Operates Differently Than Expected | 235 |
Malposition Of Device | 187 |
Protective Measures Problem | 176 |
Electrical /Electronic Property Problem | 175 |
Restricted Flow Rate | 173 |
Loss Of Power | 168 |
Contamination During Use | 159 |
Overheating Of Device | 140 |
No Display / Image | 131 |
Communication Or Transmission Problem | 123 |
Material Twisted / Bent | 121 |
Output Problem | 121 |
Device Inoperable | 119 |
Material Split, Cut Or Torn | 119 |
Kinked | 109 |
Torn Material | 102 |
Date/Time-Related Software Problem | 97 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 94 |
Naturally Worn | 92 |
Leak / Splash | 92 |
Cable | 92 |
Bent | 92 |
Noise, Audible | 88 |
Maintenance Does Not Comply To Manufacturers Recommendations | 85 |
Data Problem | 81 |
Increase In Suction | 74 |
Cut In Material | 73 |
Image Display Error / Artifact | 71 |
Appropriate Term/Code Not Available | 68 |
Migration Or Expulsion Of Device | 64 |
Crack | 64 |
Increased Pump Speed | 60 |
Low Audible Alarm | 59 |
Occlusion Within Device | 56 |
Low Readings | 48 |
Detachment Of Device Component | 46 |
Connector | 45 |
Vibration | 45 |
Electrical Power Problem | 44 |
Premature Discharge Of Battery | 42 |
Display Or Visual Feedback Problem | 42 |
Improper Flow Or Infusion | 37 |
Complete Loss Of Power | 35 |
Circuit Failure | 35 |
Failure To Power Up | 33 |
Failure To Pump | 30 |
Device Issue | 26 |
Poor Quality Image | 26 |
Cell | 26 |
Connector Pin | 25 |
Hole In Material | 24 |
Material Separation | 24 |
Detachment Of Device Or Device Component | 23 |
Fracture | 22 |
Pin | 21 |
Device Damaged Prior To Use | 21 |
Alarm | 21 |
Alarm Not Visible | 21 |
Device Misassembled During Manufacturing / Shipping | 21 |
Mechanical Problem | 20 |
Device Damaged By Another Device | 17 |
Incomplete Or Inadequate Connection | 16 |
Fitting Problem | 15 |
Temperature Problem | 15 |
Low Battery | 15 |
Device Dislodged Or Dislocated | 14 |
Improper Or Incorrect Procedure Or Method | 13 |
Difficult To Remove | 13 |
Material Discolored | 12 |
No Flow | 12 |
Deformation Due To Compressive Stress | 12 |
Misassembled | 12 |
Air Leak | 12 |
| Total Device Problems | 50784 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott | I | May-17-2018 |
| 2 | HeartWare Inc | I | Oct-17-2016 |
| 3 | HeartWare Inc | I | Jul-08-2016 |
| 4 | HeartWare Inc | II | Jun-26-2015 |
| 5 | HeartWare Inc | I | Jun-13-2015 |
| 6 | HeartWare Inc | I | Jun-11-2015 |
| 7 | HeartWare Inc | II | Jun-10-2015 |
| 8 | HeartWare Inc | I | Jun-08-2015 |
| 9 | HeartWare Inc | I | May-14-2015 |
| 10 | HeartWare Inc | I | Feb-25-2015 |
| 11 | HeartWare Inc | II | May-14-2014 |
| 12 | HeartWare Inc | I | Apr-23-2014 |
| 13 | HeartWare, Inc | I | Oct-13-2016 |
| 14 | Heartware | I | May-21-2018 |
| 15 | Heartware | I | Apr-27-2017 |
| 16 | Heartware | I | Apr-25-2017 |
| 17 | Heartware, Inc. | II | Dec-07-2018 |
| 18 | Heartware, Inc. | II | Oct-03-2018 |
| 19 | Jarvik Heart Inc | II | Dec-18-2018 |
| 20 | Thoratec Corporation | I | May-24-2017 |
| 21 | Thoratec Corporation | I | Mar-21-2014 |