TPLC - Total Product Life Cycle

• Device: cardiac ablation percutaneous catheter
• Definition: This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].
• Product Code: LPB
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
33	39	25	22	18	0

MDR Year	MDR Reports	MDR Events
2020	1182	1182
2021	1240	1240
2022	1336	1336
2023	1500	1500
2024	1841	1841

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient Device Interaction Problem	3194	3194
Adverse Event Without Identified Device or Use Problem	1350	1350
Material Puncture/Hole	440	440
Incorrect, Inadequate or Imprecise Result or Readings	380	380
Contamination /Decontamination Problem	347	347
High Readings	321	321
Failure to Sense	265	265
Signal Artifact/Noise	178	178
Device Contamination with Body Fluid	173	173
Obstruction of Flow	169	169
Insufficient Cooling	115	115
Positioning Problem	102	102
Coagulation in Device or Device Ingredient	99	99
Temperature Problem	94	94
Communication or Transmission Problem	88	88
Electrical Shorting	85	85
Display or Visual Feedback Problem	66	66
Protective Measures Problem	64	64
Material Twisted/Bent	62	62
Break	57	57
Tear, Rip or Hole in Device Packaging	54	54
Device Sensing Problem	49	49
Material Integrity Problem	45	45
Entrapment of Device	42	42
Manufacturing, Packaging or Shipping Problem	39	39
Material Protrusion/Extrusion	39	39
Image Orientation Incorrect	37	37
Appropriate Term/Code Not Available	37	37
Mechanical Jam	37	37
Erratic or Intermittent Display	32	32
Detachment of Device or Device Component	29	29
Insufficient Information	27	27
Material Split, Cut or Torn	27	27
Material Separation	27	27
Defective Device	26	26
Delivered as Unsterile Product	25	25
Complete Blockage	24	24
Packaging Problem	23	23
Crack	20	20
Device Displays Incorrect Message	20	20
Impedance Problem	20	20
Sharp Edges	19	19
Device-Device Incompatibility	18	18
Material Opacification	18	18
Failure to Deliver Energy	18	18
Partial Blockage	17	17
Infusion or Flow Problem	17	17
Expiration Date Error	17	17
Air/Gas in Device	16	16
Contamination	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cardiac Tamponade	2468	2468
No Clinical Signs, Symptoms or Conditions	2307	2307
Heart Block	350	350
No Consequences Or Impact To Patient	347	347
Stroke/CVA	277	277
Tachycardia	262	262
Cardiac Arrest	216	216
No Code Available	181	181
Cardiac Perforation	155	155
Fistula	144	144
Pericardial Effusion	116	116
Paralysis	99	99
Arrhythmia	77	77
Ischemic Heart Disease	73	73
Thrombosis/Thrombus	67	67
Stenosis	62	62
Pericarditis	60	60
Insufficient Information	59	59
Low Blood Pressure/ Hypotension	49	49
Bradycardia	47	47
Ventricular Fibrillation	46	46
Transient Ischemic Attack	44	44
Vascular Dissection	44	44
Air Embolism	43	43
Laceration(s) of Esophagus	36	36
Heart Failure/Congestive Heart Failure	34	34
Death	34	34
Pseudoaneurysm	32	32
Atrial Fibrillation	31	31
Hemorrhage/Bleeding	30	30
Pain	28	28
Vasoconstriction	27	27
No Known Impact Or Consequence To Patient	25	25
Hematoma	24	24
Perforation of Vessels	23	23
Myocardial Infarction	23	23
Paresis	22	22
Respiratory Failure	19	19
Pulmonary Edema	18	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Cardiogenic Shock	17	17
Complete Heart Block	17	17
Unspecified Tissue Injury	16	16
Pleural Effusion	15	15
Ischemia Stroke	15	15
Atrial Flutter	14	14
Asystole	13	13
Unspecified Nervous System Problem	13	13
Sepsis	12	12
Syncope/Fainting	12	12