| Device |
dilator, vessel, for percutaneous catheterization |
| Regulation Description |
Vessel dilator for percutaneous catheterization. |
| Product Code | DRE |
| Regulation Number |
870.1310
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ABBOTT |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| ARSTASIS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| AVALON |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| BOSTON SCIENTIFIC CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| C.R. BARD, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| COOK, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| COOMBS MEDICAL DEVICE CONSULTING |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| CORDIS CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| DATASCOPE CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| EDWARDS LIFESCIENCES |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| GALT MEDICAL CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| GUIDANT CORP |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| HANSEN MEDICAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| MAXXIM MEDICAL |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| MED INSTITUTE, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| MEDICAL COMPONENTS |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| MEDRAD, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| MERIT MEDICAL SYSTEMS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
5 |
| MICROVENA |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| NAVILYST MEDICAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| SHILEY, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| SPECTRANETICS CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| ST. JUDE MEDICAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| TOGO MEDIKIT CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| USCI ANGIOGRAPHY DIVISION |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
|
| Device Problems |
| Obstruction within device |
79 |
| Material separation |
78 |
| No Known Device Problem |
28 |
| Packaging issue |
17 |
| Break |
16 |
| Other (for use when an appropriate device code cannot be identified) |
14 |
| Foreign material present in device |
14 |
| Unknown (for use when the device problem is not known) |
13 |
| Foreign material |
10 |
| Leak |
9 |
| Tip breakage |
7 |
| Difficult to insert |
6 |
| Detachment of device component |
5 |
| Stretched |
5 |
| Unraveled material |
5 |
| Out-of-box failure |
5 |
| Wire(s), breakage of |
5 |
| Occlusion within device |
4 |
| Kinked |
4 |
| Fracture |
4 |
| Fluid leak |
3 |
| Difficult to flush |
3 |
| Difficult to remove |
3 |
| Prep, failure to |
3 |
| Device damaged prior to use |
3 |
| No Pressure |
3 |
| Sterility |
3 |
| Difficult to advance |
2 |
| Use of Device Issue |
2 |
| Defective item |
2 |
| Sharp/jagged/rough/etched/scratched |
2 |
| Seal, defective |
2 |
| Tears, rips, holes in device, device material |
2 |
| Unsealed device packaging |
2 |
| Air leak |
2 |
| Balloon leak(s) |
1 |
| Blockage within device or device component |
1 |
| Component(s), broken |
1 |
| Contamination during use |
1 |
| Crack |
1 |
| Difficult to deploy |
1 |
| Entrapment of device or device component |
1 |
| Mechanical issue |
1 |
| Melted |
1 |
| Premature deployment |
1 |
| Retraction problem |
1 |
| Rupture, cause unknown |
1 |
| Product quality issue |
1 |
| Reflux within device |
1 |
| Device, or device fragments remain in patient |
1 |
| Shaft break |
1 |
| Stopcock valve, failure of |
1 |
| Device, removal of (non-implant) |
1 |
| Catheter withdrawal interference |
1 |
| Detachment of device or device component |
1 |
| Device operates differently than expected |
1 |
| Device packaging compromised |
1 |
| Human factors issue |
1 |
| Human-Device Interface Issue |
1 |
| Item contaminated during manufacturing or shipping |
1 |
| Solder joint failure |
1 |
| Tear, rip or hole in device packaging |
1 |
| Structural problem |
1 |
| Split |
1 |
| No Information |
1 |
| Total Device Problems |
395 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
1 |
2 |
1 |
0 |
0 |
| Class III |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
|
|
|
