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)
2019	2020	2021	2022	2023	2024
30	33	39	25	22	9

MDR Year	MDR Reports	MDR Events
2019	1124	1124
2020	1182	1182
2021	1241	1241
2022	1336	1336
2023	1500	1500
2024	1148	1148

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient Device Interaction Problem	3045	3045
Adverse Event Without Identified Device or Use Problem	1740	1740
Material Puncture/Hole	589	589
Incorrect, Inadequate or Imprecise Result or Readings	335	335
Contamination /Decontamination Problem	327	327
High Readings	314	314
Failure to Sense	222	222
Signal Artifact/Noise	166	166
Device Contamination with Body Fluid	160	160
Coagulation in Device or Device Ingredient	141	141
Obstruction of Flow	127	127
Insufficient Cooling	99	99
Positioning Problem	93	93
Temperature Problem	88	88
Communication or Transmission Problem	86	86
Electrical Shorting	84	84
Display or Visual Feedback Problem	61	61
Protective Measures Problem	59	59
Tear, Rip or Hole in Device Packaging	58	58
Break	56	56
Material Twisted/Bent	56	56
Entrapment of Device	53	53
Material Split, Cut or Torn	51	51
Device Sensing Problem	48	48
Appropriate Term/Code Not Available	45	45
Material Integrity Problem	43	43
Crack	41	41
Sharp Edges	39	39
Detachment of Device or Device Component	38	38
Mechanical Jam	37	37
Material Protrusion/Extrusion	37	37
Image Orientation Incorrect	34	34
Erratic or Intermittent Display	31	31
Defective Device	29	29
Delivered as Unsterile Product	28	28
Device Remains Activated	28	28
Material Separation	28	28
Insufficient Information	26	26
Device Contamination with Chemical or Other Material	26	26
Manufacturing, Packaging or Shipping Problem	24	24
Complete Blockage	22	22
Packaging Problem	21	21
Expiration Date Error	21	21
Device Displays Incorrect Message	20	20
No Display/Image	18	18
Impedance Problem	18	18
Failure to Deliver Energy	18	18
Partial Blockage	17	17
Contamination	15	15
Separation Problem	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cardiac Tamponade	2804	2804
No Clinical Signs, Symptoms or Conditions	2050	2050
No Consequences Or Impact To Patient	741	741
No Code Available	343	343
Heart Block	318	318
Stroke/CVA	306	306
Cardiac Arrest	246	246
Fistula	174	174
Cardiac Perforation	156	156
Pericardial Effusion	125	125
Paralysis	105	105
Arrhythmia	86	86
Death	85	85
Ischemic Heart Disease	68	68
Stenosis	66	66
Thrombosis/Thrombus	64	64
Pericarditis	58	58
No Known Impact Or Consequence To Patient	57	57
Insufficient Information	56	56
Ventricular Fibrillation	54	54
Transient Ischemic Attack	50	50
Low Blood Pressure/ Hypotension	49	49
Pseudoaneurysm	46	46
Bradycardia	45	45
Air Embolism	44	44
Vascular Dissection	43	43
Laceration(s) of Esophagus	36	36
Tachycardia	33	33
Complete Heart Block	32	32
Heart Failure/Congestive Heart Failure	31	31
Hemorrhage/Bleeding	30	30
Vasoconstriction	28	28
Myocardial Infarction	27	27
Hematoma	27	27
Perforation of Vessels	26	26
Paresis	22	22
Respiratory Failure	18	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Pulmonary Edema	17	17
Cardiogenic Shock	17	17
Pleural Effusion	16	16
Sepsis	15	15
Unspecified Tissue Injury	15	15
Pain	14	14
Blood Loss	13	13
Asystole	13	13
Unspecified Nervous System Problem	11	11
Thrombosis	11	11
Nerve Damage	11	11
Inflammation	11	11