TPLC - Total Product Life Cycle

• Device: catheter, coronary, atherectomy
• Product Code: MCX
• Device Class: 3

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013
8	8	10	5	12	10	3

Device Problems
Difficult to remove	156
No Known Device Problem	150
Unknown (for use when the device problem is not known)	144
Wire(s), breakage of	112
Fracture	108
Entrapment of device or device component	95
Detachment of device or device component	48
Device operates differently than expected	46
Device, or device fragments remain in patient	45
Balloon rupture	39
No display or display failure	36
Break	33
Detachment of device component	29
Foreign material present in device	28
Kinked	23
Device damaged prior to use	21
Use of Device Issue	21
Other (for use when an appropriate device code cannot be identified)	15
Failure to advance	15
Tip breakage	15
No Information	14
Device or device component damaged by another device	12
Physical resistance	12
Foreign material	11
Leak	11
Difficult to insert	10
Tears, rips, holes in device, device material	9
Device Issue	9
Material perforation	8
Stretched	8
Malfunction	8
Unstable	8
Sticking	8
Unintended movement	6
Difficult to advance	6
Fluid leak	6
Hole in material	6
Air leak	5
Device or device fragments location unknown	5
Difficult to position	4
Torn material	4
Disconnection	4
Device remains activated	3
Device, removal of (non-implant)	3
Device stops intermittently	3
Decrease in pressure	3
Defective component	3
Device Difficult to Setup or Prepare	3
Split	3
Material fragmentation	3
Bent	2
Declotting	2
Device operational issue	2
Material twisted	2
Source, detachment from	2
Dissection	2
Tear, rip or hole in device packaging	2
Shaft break	2
Blockage within device or device component	2
Dislodged	2
Material deformation	2
Unraveled material	2
High Readings	2
Flaked	2
Material frayed	1
Loose or intermittent connection	1
Delivered as unsterile product	1
Output above specifications	1
Erratic display	1
Failure, intermittent	1
Bleed back	1
Balloon pinhole	1
Connection issue	1
Failure to select signal	1
Pressure issue	1
Improper device output	1
Output energy incorrect	1
Peeled	1
Bubble(s)	1
Device inoperable	1
Deflation issue	1
Material puncture	1
Failure to flush	1
Mislabeled	1
Difficult to open or remove packaging material	1
Dislodged or dislocated	1
No flow	1
Gas leak	1
Material separation	1
Sterility	1
Unsealed device packaging	1
Failure to power-up	1
Total Device Problems	1433

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	1	0	0	0	0	0	0
Class III	1	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Possis Medical, Inc	III	Jun-21-2007
2	St Jude Medical CRMD	II	Jun-14-2007