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	11

MDR Year	MDR Reports	MDR Events
2020	1182	1182
2021	1240	1240
2022	1336	1336
2023	1500	1500
2024	1840	1840
2025	443	443

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient Device Interaction Problem	3352	3352
Adverse Event Without Identified Device or Use Problem	1372	1372
Incorrect, Inadequate or Imprecise Result or Readings	446	446
Material Puncture/Hole	440	440
Contamination /Decontamination Problem	364	364
High Readings	325	325
Failure to Sense	316	316
Obstruction of Flow	212	212
Signal Artifact/Noise	197	197
Device Contamination with Body Fluid	188	188
Insufficient Cooling	144	144
Coagulation in Device or Device Ingredient	112	112
Positioning Problem	111	111
Temperature Problem	101	101
Communication or Transmission Problem	98	98
Electrical Shorting	92	92
Display or Visual Feedback Problem	72	72
Protective Measures Problem	69	69
Material Twisted/Bent	68	68
Break	61	61
Manufacturing, Packaging or Shipping Problem	60	60
Tear, Rip or Hole in Device Packaging	60	60
Device Sensing Problem	55	55
Material Integrity Problem	50	50
Entrapment of Device	44	44
Material Protrusion/Extrusion	42	42
Image Orientation Incorrect	41	41
Mechanical Jam	39	39
Erratic or Intermittent Display	37	37
Appropriate Term/Code Not Available	37	37
Detachment of Device or Device Component	30	30
Material Separation	28	28
Delivered as Unsterile Product	27	27
Insufficient Information	27	27
Material Split, Cut or Torn	27	27
Defective Device	26	26
Complete Blockage	25	25
Packaging Problem	24	24
Impedance Problem	22	22
Crack	20	20
Material Opacification	20	20
Device Displays Incorrect Message	20	20
Failure to Deliver Energy	20	20
Sharp Edges	19	19
Device-Device Incompatibility	19	19
Infusion or Flow Problem	18	18
Air/Gas in Device	18	18
Contamination	18	18
Partial Blockage	17	17
Expiration Date Error	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2574	2574
Cardiac Tamponade	2555	2555
Heart Block	366	366
No Consequences Or Impact To Patient	347	347
Stroke/CVA	294	294
Tachycardia	264	264
Cardiac Arrest	234	234
No Code Available	181	181
Cardiac Perforation	169	169
Fistula	149	149
Pericardial Effusion	117	117
Paralysis	100	100
Arrhythmia	80	80
Ischemic Heart Disease	77	77
Thrombosis/Thrombus	70	70
Pericarditis	65	65
Stenosis	65	65
Insufficient Information	63	63
Ventricular Fibrillation	52	52
Low Blood Pressure/ Hypotension	52	52
Vascular Dissection	51	51
Bradycardia	49	49
Air Embolism	44	44
Transient Ischemic Attack	44	44
Heart Failure/Congestive Heart Failure	37	37
Laceration(s) of Esophagus	36	36
Death	34	34
Pseudoaneurysm	32	32
Atrial Fibrillation	31	31
Hemorrhage/Bleeding	30	30
Pain	30	30
Vasoconstriction	29	29
No Known Impact Or Consequence To Patient	25	25
Myocardial Infarction	25	25
Hematoma	24	24
Respiratory Failure	23	23
Perforation of Vessels	23	23
Paresis	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Pulmonary Edema	18	18
Cardiogenic Shock	17	17
Complete Heart Block	17	17
Unspecified Tissue Injury	16	16
Ischemia Stroke	15	15
Pleural Effusion	15	15
Atrial Flutter	14	14
Syncope/Fainting	13	13
Asystole	13	13
Unspecified Nervous System Problem	13	13
Sepsis	12	12