| Device |
catheter, flow directed |
| Regulation Description |
Flow-directed catheter. |
| Product Code | DYG |
| Regulation Number |
870.1240
|
|---|
| Device Class |
2
|
| Device Problems |
| Failure to pace or properly pace |
149 |
| Inflation issue |
126 |
| Measurements, inaccurate |
107 |
| Balloon leak(s) |
89 |
| Deflation issue |
85 |
| Material rupture |
64 |
| Incorrect or inadequate result |
63 |
| Fluid leak |
54 |
| Incorrect measurement |
35 |
| Other (for use when an appropriate device code cannot be identified) |
35 |
| Balloon rupture |
33 |
| Break |
31 |
| Leak |
27 |
| No code available |
24 |
| Unable to obtain readings |
21 |
| Detachment of device component |
21 |
| Air leak |
20 |
| Contamination during use |
19 |
| No Known Device Problem |
18 |
| Unknown (for use when the device problem is not known) |
15 |
| Low readings |
15 |
| Burst |
15 |
| Incorrect display |
12 |
| Balloon burst |
11 |
| Difficult to remove |
11 |
| Component missing |
9 |
| Device operates differently than expected |
9 |
| High Readings |
8 |
| Source, detachment from |
8 |
| Difficult to insert |
7 |
| Interlumen communication |
6 |
| Kinked |
6 |
| Hole in material |
6 |
| Cut in material |
5 |
| Foreign material present in device |
5 |
| Gas leak |
4 |
| Failure to sterilize |
4 |
| Difficult to position |
4 |
| Material fragmentation |
4 |
| Deflation due to damage from surgical instrument |
4 |
| Crack |
4 |
| Deflation, cause unknown |
3 |
| No display or display failure |
3 |
| Difficult to flush |
3 |
| Foreign material |
3 |
| Entrapment of device or device component |
3 |
| False reading from device non-compliance |
3 |
| Component(s), broken |
3 |
| Bleed back |
3 |
| Balloon asymmetrical |
3 |
| Occlusion within device |
3 |
| No device output |
3 |
| Unsealed device packaging |
3 |
| Material separation |
3 |
| Material perforation |
3 |
| Blood in tubing |
3 |
| Defective component |
3 |
| Detachment of device or device component |
3 |
| Deployment issue |
2 |
| Defective item |
2 |
| Material integrity issue |
2 |
| Output issue |
2 |
| Positioning Issue |
2 |
| Difficult to advance |
2 |
| Failure to expand |
2 |
| Failure to sense |
2 |
| Electrical wires, defective |
2 |
| Device Issue |
2 |
| Pressure, insufficient |
2 |
| Device damaged prior to use |
2 |
| Unstable |
2 |
| Use of Device Issue |
2 |
| Wedge, difficult to |
2 |
| Wavelength, incorrect |
2 |
| Sterility |
2 |
| Tip breakage |
2 |
| Tubing, incorrect placement of |
2 |
| Failure to read input signal |
2 |
| Rupture, cause unknown |
2 |
| Material puncture |
2 |
| Plugged |
2 |
| Material frayed |
2 |
| Mechanical issue |
2 |
| Misassembled |
2 |
| Knotted |
2 |
| Looping |
2 |
| Loose |
1 |
| Markings unclear |
1 |
| Mislabeled |
1 |
| Difficult to Program or Calibrate |
1 |
| Particulates |
1 |
| Pacing inadequately |
1 |
| Rupture, fold or crease due to |
1 |
| Bent |
1 |
| Changes in ambient temperature in device environment |
1 |
| Aspiration, excessive |
1 |
| Blockage within device or device component |
1 |
| Burn of device or device component |
1 |
| Coiled |
1 |
| Filter leak(s) |
1 |
| Total Device Problems |
1314 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
2014 |
2015 |
2016 |
2017 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
2 |
0 |
1 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
