| Device Type ID | 3840 |
| Device Name | Agent, Injectable, Embolic |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MFE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3840 |
| Device | Agent, Injectable, Embolic |
| Product Code | MFE |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 504 |
Migration Or Expulsion Of Device | 90 |
Detachment Of Device Component | 38 |
Entrapment Of Device | 32 |
Burst Container Or Vessel | 25 |
Device Operates Differently Than Expected | 12 |
Break | 12 |
Leak / Splash | 11 |
Difficult To Remove | 9 |
Unintended Movement | 8 |
Detachment Of Device Or Device Component | 8 |
Device Damaged By Another Device | 6 |
Component Or Accessory Incompatibility | 4 |
Reflux Within Device | 4 |
Premature Separation | 4 |
Appropriate Term/Code Not Available | 4 |
Failure To Deliver | 3 |
Therapy Delivered To Incorrect Body Area | 3 |
Separation Failure | 2 |
Off-Label Use | 2 |
Thermal Decomposition Of Device | 2 |
Material Rupture | 2 |
Insufficient Information | 2 |
Premature Activation | 2 |
No Apparent Adverse Event | 2 |
Physical Resistance | 2 |
Patient-Device Incompatibility | 2 |
Human-Device Interface Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Physical Property Issue | 1 |
Coagulation In Device Or Device Ingredient | 1 |
Occlusion Within Device | 1 |
Chemical Problem | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Separation Problem | 1 |
Malposition Of Device | 1 |
Improper Chemical Reaction | 1 |
Kinked | 1 |
Material Separation | 1 |
Sticking | 1 |
Optical Problem | 1 |
Adhesive | 1 |
Physical Resistance / Sticking | 1 |
| Total Device Problems | 811 |