| Device |
catheter, urological |
| Regulation Description |
Urological catheter and accessories. |
| Product Code | KOD |
| Regulation Number |
876.5130
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ABCO DEALERS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
9 |
| BAXTER HEALTHCARE CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| BEIERSDORF |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| BIOSEARCH MEDICAL PRODUCTS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| BOSTON SCIENTIFIC CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
5 |
| C.R. BARD, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
7 |
| |
SUBSTANTIALLY EQUIVALENT - KIT
|
1 |
| |
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
|
1 |
| COLOPLAST MANUFACTURING US LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| COOK, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
7 |
| ENDOCARE, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| GO MEDICAL INDUSTRIES PTY. LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| HOLLISTER, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| INAMED CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
5 |
| KENDALL |
| |
SUBSTANTIALLY EQUIVALENT
|
12 |
| LEVEL 1 |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| MEADOX |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| MEDLINE |
| |
SUBSTANTIALLY EQUIVALENT
|
5 |
| MEDTRONIC, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| PLUROMED, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3 |
| RESPIRATORY SUPPORT PRODUCTS, INC. (RSP) |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| ROCHE DIAGNOSTICS CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| SHERIDAN CATHETER CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| TERUMO CARDIOVASCULAR SYSTEMS |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| TYCO HEALTHCARE |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| VANCE PRODUCTS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
5 |
| WELCON, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
|
| Device Problems |
| Deflation issue |
66 |
| Other (for use when an appropriate device code cannot be identified) |
35 |
| Failure to disconnect |
35 |
| Balloon burst |
33 |
| Failure to advance |
28 |
| Detachment of device component |
20 |
| Peeled |
20 |
| Inflation issue |
16 |
| Burst |
14 |
| Break |
12 |
| Premature deployment |
11 |
| Failure to deploy |
10 |
| Difficult to remove |
9 |
| Device, or device fragments remain in patient |
8 |
| Difficult to deploy |
8 |
| Device Issue |
6 |
| Defective item |
6 |
| Close, difficult to |
6 |
| No Known Device Problem |
5 |
| Misapplication |
5 |
| Deflation, cause unknown |
5 |
| Leak |
5 |
| Foreign material |
4 |
| Balloon rupture |
4 |
| Mislabeled |
4 |
| Material separation |
4 |
| Tip breakage |
4 |
| Failure to separate |
4 |
| Difficult to open or close |
4 |
| Device, removal of (non-implant) |
3 |
| No code available |
3 |
| Unknown (for use when the device problem is not known) |
3 |
| Source, detachment from |
3 |
| Tears, rips, holes in device, device material |
3 |
| Failure to deliver |
3 |
| Unsealed device packaging |
3 |
| Component(s), broken |
3 |
| Device expiration issue |
3 |
| Flaked |
3 |
| Device maintenance issue |
3 |
| Material fragmentation |
3 |
| Blockage within device or device component |
2 |
| Disassembly |
2 |
| Replace |
2 |
| Slippage of device or device component |
2 |
| Material rupture |
2 |
| Inadequate instructions for healthcare professional |
2 |
| Kinked |
2 |
| Malfunction |
2 |
| Packaging issue |
2 |
| Difficult to advance |
2 |
| Patient-device incompatibility |
2 |
| Detachment of device or device component |
2 |
| Device or device component damaged by another device |
1 |
| Foreign material present in device |
1 |
| Incorrect device or component shipped |
1 |
| Item contaminated during manufacturing or shipping |
1 |
| Manufacturing or shipping issue associated with device |
1 |
| Material deformation |
1 |
| Leaflet disruption, cause unknown |
1 |
| Catheter withdrawal interference |
1 |
| Device or device fragments location unknown |
1 |
| Not Applicable |
1 |
| Cut in material |
1 |
| Structural problem |
1 |
| Tear, rip or hole in device packaging |
1 |
| Wire(s), breakage of |
1 |
| Material perforation |
1 |
| Device damaged prior to use |
1 |
| Defective component |
1 |
| Incomplete or missing packaging |
1 |
| Unraveled material |
1 |
| Use of Device Issue |
1 |
| Improper or incorrect procedure or method |
1 |
| Misassembled |
1 |
| Delivered as unsterile product |
1 |
| User used incorrect product for intended use |
1 |
| Rupture, cause unknown |
1 |
| Material rigid or stiff |
1 |
| Material discolored |
1 |
| Disengaged |
1 |
| Balloon leak(s) |
1 |
| Bent |
1 |
| Contamination during use |
1 |
| Crack |
1 |
| Material frayed |
1 |
| Difficult to insert |
1 |
| Melted |
1 |
| Migration of device or device component |
1 |
| Inaccurate flowrate |
1 |
| Difficult to flush |
1 |
| Failure to flush |
1 |
| Unintended ejection |
1 |
| Fire |
1 |
| Fracture |
1 |
| Total Device Problems |
493 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
1 |
1 |
3 |
3 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
