TPLC - Total Product Life Cycle

• Device: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation
• Definition: For the treatment of atrial fibrillation.
• Product Code: QZI
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025	2026
0	0	0	1	16	40	20

MDR Year	MDR Reports	MDR Events
2024	1430	1431
2025	4129	4129
2026	1868	1868

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2618	2619
Entrapment of Device	915	915
Material Deformation	685	685
Material Twisted/Bent	638	638
Off-Label Use	533	533
Detachment of Device or Device Component	360	360
Patient Device Interaction Problem	338	338
Material Integrity Problem	306	306
Device Contamination with Chemical or Other Material	284	284
Fluid/Blood Leak	223	223
Improper Flow or Infusion	219	219
Contamination	195	195
Break	141	141
Use of Device Problem	139	139
Nonstandard Device	138	138
Difficult to Flush	128	128
Positioning Failure	126	126
Difficult to Remove	121	121
Air/Gas in Device	115	115
Activation, Positioning or Separation Problem	107	107
Coagulation in Device or Device Ingredient	84	84
Restricted Flow rate	81	81
Defective Device	67	67
No Apparent Adverse Event	65	65
Thermal Decomposition of Device	55	55
Device-Device Incompatibility	54	54
Difficult to Advance	47	47
Communication or Transmission Problem	39	39
Tear, Rip or Hole in Device Packaging	38	38
Unsealed Device Packaging	36	36
Packaging Problem	27	27
Human-Device Interface Problem	27	27
Mechanical Jam	24	24
Positioning Problem	23	23
Delivered as Unsterile Product	23	23
Activation Failure	21	21
Physical Resistance/Sticking	19	19
Obstruction of Flow	18	18
Insufficient Information	17	17
Therapeutic or Diagnostic Output Failure	17	17
Clumping in Device or Device Ingredient	17	17
Signal Artifact/Noise	16	16
Difficult or Delayed Activation	16	16
Device Displays Incorrect Message	15	15
Output Problem	15	15
High Readings	13	13
Deformation Due to Compressive Stress	13	13
Unintended Movement	13	13
Device Contaminated During Manufacture or Shipping	13	13
Noise, Audible	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3962	3962
Pericardial Effusion	599	599
Low Blood Pressure/ Hypotension	557	557
Stroke/CVA	374	374
Cardiac Tamponade	338	338
Non specific EKG/ECG Changes	269	269
Atrial Fibrillation	193	194
Arrhythmia	188	188
Heart Block	184	184
Cardiac Arrest	177	177
Unspecified Tissue Injury	167	167
Tachycardia	158	158
Bradycardia	156	156
Cardiac Perforation	146	146
Syncope/Fainting	143	143
Chest Pain	121	121
Ventricular Fibrillation	110	110
Ischemia Stroke	102	102
Hemolysis	101	101
Hemorrhage/Bleeding	101	101
Vasoconstriction	98	98
Atrial Flutter	89	89
Dyspnea	86	86
Pericarditis	81	81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	72	72
Transient Ischemic Attack	72	72
Thrombosis/Thrombus	67	67
Asystole	62	62
Nerve Damage	60	60
Heart Failure/Congestive Heart Failure	59	59
Renal Failure	50	50
Air Embolism	49	49
Hypoxia	49	49
Hematoma	46	46
Muscle Weakness	43	43
Visual Disturbances	36	36
Dizziness	36	36
Hematuria	35	35
Perforation	35	35
Insufficient Information	35	35
Pain	34	34
High Blood Pressure/ Hypertension	33	33
Cramp(s) /Muscle Spasm(s)	29	29
Embolism/Embolus	28	28
Pleural Effusion	28	28
Speech Disorder	27	27
Myocardial Infarction	27	27
Blurred Vision	27	27
Numbness	26	26
Cardiogenic Shock	25	25

Recalls
Manufacturer		Recall Class	Date Posted
1	Biosense Webster, Inc.	I	Feb-28-2025
2	Boston Scientific Corporation	II	Aug-08-2025