TPLC - Total Product Life Cycle

Device	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Definition	For the treatment of atrial flutter.
Product Code	OAD
Device Class	3

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013
14	8	9	12	20	19	8

Device Problems
Detachment of device component	189
No Known Device Problem	125
Leak	97
Device operates differently than expected	28
Temperature issue	14
Charred	9
Device operational issue	9
Difficult to remove	7
Component(s), broken	6
Fluid leak	6
Kinked	6
No Information	5
Material separation	4
Bent	3
Device packaging compromised	3
Break	3
Burn of device or device component	3
High impedance	3
Inability to irrigate	2
Device remains activated	2
Difficult or delayed activation	2
Difficult to advance	1
Restricted flowrate	1
Loose or intermittent connection	1
Occlusion within device	1
R on T phenomenon	1
Crack	1
Mechanical issue	1
Overheating of device or device component	1
Smoking	1
Use of Device Issue	1
Incorrect or inadequate test results	1
Split	1
Failure to shut off	1
Hole in material	1
Loss of power	1
Device Issue	1
Communication or transmission issue	1
Material discolored	1
Prep, failure to	1
Failure to read input signal	1
Low impedance	1
Defective component	1
Tear, rip or hole in device packaging	1
Electronic property issue	1
Total Device Problems	550