| Device Type ID | 1044 |
| Device Name | System, Appendage Closure, Left Atrial |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | PMA |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | NGV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1044 |
| Device | System, Appendage Closure, Left Atrial |
| Product Code | NGV |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2162 |
Difficult To Remove | 285 |
Catheter | 203 |
Kinked | 138 |
Leak / Splash | 106 |
Hemo Valve | 103 |
Tip | 63 |
Material Deformation | 61 |
Air Leak | 42 |
Torn Material | 39 |
Bent | 30 |
Detachment Of Device Or Device Component | 27 |
Device Dislodged Or Dislocated | 24 |
Difficult To Open Or Close | 18 |
Positioning Problem | 17 |
Material Integrity Problem | 14 |
Migration | 10 |
Activation, Positioning Or Separation Problem | 9 |
Hole In Material | 9 |
Premature Activation | 8 |
Break | 6 |
Device Contamination With Chemical Or Other Material | 6 |
Gas Leak | 6 |
Detachment Of Device Component | 5 |
Material Separation | 4 |
Wire | 4 |
Shaft | 3 |
Device Packaging Compromised | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Crack | 3 |
Difficult To Advance | 3 |
Hub | 3 |
Difficult To Insert | 2 |
Fluid Leak | 2 |
Difficult To Open Or Remove Packaging Material | 2 |
Packaging Problem | 2 |
Defective Device | 2 |
Device-Device Incompatibility | 2 |
Material Protrusion / Extrusion | 2 |
Difficult Or Delayed Positioning | 2 |
Contamination / Decontamination Problem | 2 |
Connection Problem | 2 |
Physical Resistance | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Failure To Advance | 2 |
Port | 2 |
Contamination During Use | 2 |
Unstable | 1 |
Frame | 1 |
Fracture | 1 |
Material Twisted / Bent | 1 |
Cap | 1 |
Material Split, Cut Or Torn | 1 |
Stopcock | 1 |
Difficult To Flush | 1 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
Device Damaged By Another Device | 1 |
Material Fragmentation | 1 |
Unintended Movement | 1 |
Physical Resistance / Sticking | 1 |
Cut In Material | 1 |
Split | 1 |
Entrapment Of Device | 1 |
Device Damaged Prior To Use | 1 |
| Total Device Problems | 3465 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biosense Webster, Inc. | I | Aug-30-2018 |
| 2 | Boston Scientific Corporation | II | Nov-11-2015 |