| 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 |
116 |
| Measurements, inaccurate |
107 |
| Inflation issue |
92 |
| Balloon leak(s) |
70 |
| Deflation issue |
59 |
| Fluid leak |
44 |
| Material rupture |
40 |
| Other (for use when an appropriate device code cannot be identified) |
35 |
| Incorrect measurement |
34 |
| Balloon rupture |
32 |
| Break |
26 |
| Incorrect or inadequate result |
20 |
| Contamination during use |
19 |
| Air leak |
15 |
| Unknown (for use when the device problem is not known) |
15 |
| Low readings |
15 |
| No code available |
14 |
| Unable to obtain readings |
14 |
| Detachment of device component |
12 |
| Burst |
10 |
| Difficult to remove |
10 |
| Component missing |
9 |
| High Readings |
8 |
| Source, detachment from |
8 |
| Balloon burst |
6 |
| Difficult to insert |
6 |
| Interlumen communication |
6 |
| Leak |
5 |
| Hole in material |
4 |
| Failure to sterilize |
4 |
| Crack |
4 |
| Deflation due to damage from surgical instrument |
4 |
| Cut in material |
4 |
| Detachment of device or device component |
3 |
| Device operates differently than expected |
3 |
| Gas leak |
3 |
| Blood in tubing |
3 |
| Material perforation |
3 |
| Deflation, cause unknown |
3 |
| False reading from device non-compliance |
3 |
| Kinked |
3 |
| Difficult to flush |
3 |
| Foreign material |
3 |
| Bleed back |
3 |
| Component(s), broken |
3 |
| Balloon asymmetrical |
3 |
| Unsealed device packaging |
3 |
| Plugged |
2 |
| Difficult to position |
2 |
| Misassembled |
2 |
| Material frayed |
2 |
| Looping |
2 |
| Sterility |
2 |
| Tip breakage |
2 |
| Tubing, incorrect placement of |
2 |
| No device output |
2 |
| Rupture, cause unknown |
2 |
| Failure to sense |
2 |
| Material separation |
2 |
| Failure to read input signal |
2 |
| Unstable |
2 |
| Use of Device Issue |
2 |
| Wedge, difficult to |
2 |
| Wavelength, incorrect |
2 |
| Device Issue |
2 |
| Pressure, insufficient |
2 |
| No Known Device Problem |
2 |
| Positioning Issue |
2 |
| Electrical wires, defective |
2 |
| Defective item |
2 |
| Patient-device incompatibility |
1 |
| Blocked connection |
1 |
| Communication or transmission issue |
1 |
| Structural problem |
1 |
| Failure to advance |
1 |
| Failure to obtain samples |
1 |
| Difficult or delayed activation |
1 |
| Foreign material present in device |
1 |
| No Information |
1 |
| Material integrity issue |
1 |
| Malfunction |
1 |
| Failure to calibrate |
1 |
| Improper or incorrect procedure or method |
1 |
| Suction issue |
1 |
| Incomplete or missing packaging |
1 |
| Device damaged prior to use |
1 |
| Blood gas measurements, erroneous |
1 |
| Invalid sensing |
1 |
| Rupture, fold or crease due to |
1 |
| Twisting |
1 |
| Tube(s), splitting of |
1 |
| Stretched |
1 |
| Loose |
1 |
| Markings unclear |
1 |
| Mechanical issue |
1 |
| Mislabeled |
1 |
| Pacing inadequately |
1 |
| Material puncture |
1 |
| Particulates |
1 |
| Bent |
1 |
| Total Device Problems |
985 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
2 |
0 |
1 |
0 |
0 |
1 |
1 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
