Definition: The Device Is A Polymerizing Agent Intended For Permanent Occlusion Of Peripheral Blood Vessels.
Device Type ID | 1081 |
Device Name | Agent, Occluding, Vascular, Permanent |
Physical State | The Device Consists Of A Polymerizing Glue And Delivery System For Injection Into The Vasculature. |
Technical Method | The Material Polymerizes In The Vessel To Permanently Coapt Or Occlude The Vessel. |
Target Area | Peripheral Vasculature |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | PJQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1081 |
Device | Agent, Occluding, Vascular, Permanent |
Product Code | PJQ |
FDA Device Classification | Class 3 Medical Device |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 193 |
Migration Or Expulsion Of Device | 4 |
Material Deformation | 4 |
Partial Blockage | 2 |
Defective Device | 2 |
Detachment Of Device Or Device Component | 2 |
Device Operates Differently Than Expected | 2 |
Material Puncture / Hole | 2 |
Obstruction Of Flow | 2 |
Deformation Due To Compressive Stress | 2 |
Use Of Device Problem | 1 |
Failure To Deliver | 1 |
Device Difficult To Setup Or Prepare | 1 |
Occlusion Within Device | 1 |
Misfire | 1 |
Torn Material | 1 |
Break | 1 |
Mechanical Problem | 1 |
Stretched | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Off-Label Use | 1 |
Total Device Problems | 226 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Covidien LLC | II | May-12-2015 |