Definition: This Device Is A Single Use Percutaneous Catheter System That Is Introduced Into An Artery Through The Skin Using A Guidewire. The Catheter Has An Embolic Capture Filter Or An Occlusion Balloon At The Distal End. The Filter Or Balloon Can Be Placed E
| Device Type ID | 921 |
| Device Name | Temporary Carotid Catheter For Embolic Capture |
| Regulation Description | Percutaneous Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NTE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 921 |
| Device | Temporary Carotid Catheter For Embolic Capture |
| Product Code | NTE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous Catheter. |
| CFR Regulation Number | 870.1250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GARDIA MEDICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SILK ROAD MEDICAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SILK ROAD MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 156 |
Difficult To Remove | 49 |
Filter | 48 |
Detachment Of Device Or Device Component | 44 |
Retraction Problem | 19 |
Catheter | 19 |
Break | 18 |
Detachment Of Device Component | 17 |
Material Separation | 17 |
Deflation Problem | 14 |
Improper Or Incorrect Procedure Or Method | 14 |
Difficult To Advance | 12 |
Tip | 9 |
Difficult To Insert | 8 |
Stretched | 8 |
Material Deformation | 8 |
Leak / Splash | 7 |
Off-Label Use | 7 |
Kinked | 7 |
Torn Material | 6 |
Unraveled Material | 6 |
Defective Component | 6 |
Guidewire | 5 |
Migration | 5 |
Device Operates Differently Than Expected | 5 |
Bent | 5 |
Burst Container Or Vessel | 5 |
Material Split, Cut Or Torn | 5 |
Entrapment Of Device | 5 |
Defective Device | 4 |
Stent | 4 |
Activation, Positioning Or Separation Problem | 4 |
Material Frayed | 4 |
Failure To Advance | 4 |
Fracture | 3 |
Migration Or Expulsion Of Device | 3 |
Device Damaged By Another Device | 3 |
Positioning Failure | 2 |
Peeled / Delaminated | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Insufficient Information | 2 |
Material Too Soft / Flexible | 2 |
Device Markings / Labelling Problem | 2 |
Device Damaged Prior To Use | 2 |
Difficult Or Delayed Activation | 2 |
Material Twisted / Bent | 2 |
Compatibility Problem | 2 |
Product Quality Problem | 2 |
Balloon | 2 |
Difficult Or Delayed Positioning | 2 |
Activation Failure Including Expansion Failures | 2 |
Wire | 1 |
Coiled | 1 |
Occlusion Within Device | 1 |
Device Dislodged Or Dislocated | 1 |
Looping | 1 |
Device Difficult To Setup Or Prepare | 1 |
Component Missing | 1 |
Deformation Due To Compressive Stress | 1 |
Delamination | 1 |
Failure To Capture | 1 |
Physical Resistance | 1 |
Inflation Problem | 1 |
Malposition Of Device | 1 |
Device Expiration Issue | 1 |
Difficult To Position | 1 |
Blocked Connection | 1 |
Sticking | 1 |
Device-Device Incompatibility | 1 |
Hole In Material | 1 |
Unsealed Device Packaging | 1 |
Under-Sensing | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 613 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Vascular, Inc. | II | Mar-27-2014 |