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)
2019	2020	2021	2022	2023	2024	2025	2026
0	0	0	0	1	16	40	3

MDR Year	MDR Reports	MDR Events
2024	1430	1431
2025	4131	4131

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1801	1802
Entrapment of Device	775	775
Material Twisted/Bent	533	533
Material Deformation	517	517
Off-Label Use	456	456
Detachment of Device or Device Component	315	315
Material Integrity Problem	299	299
Device Contamination with Chemical or Other Material	249	249
Patient Device Interaction Problem	225	225
Improper Flow or Infusion	219	219
Fluid/Blood Leak	163	163
Positioning Failure	125	125
Use of Device Problem	106	106
Difficult to Remove	98	98
Break	98	98
Activation, Positioning or Separation Problem	95	95
Air/Gas in Device	95	95
Difficult to Flush	93	93
Contamination	90	90
Coagulation in Device or Device Ingredient	79	79
Defective Device	61	61
Nonstandard Device	53	53
Device-Device Incompatibility	46	46
Thermal Decomposition of Device	43	43
Tear, Rip or Hole in Device Packaging	35	35
Unsealed Device Packaging	33	33
Difficult to Advance	32	32
Restricted Flow rate	31	31
No Apparent Adverse Event	30	30
Packaging Problem	23	23
Mechanical Jam	18	18
Positioning Problem	16	16
Insufficient Information	15	15
Clumping in Device or Device Ingredient	15	15
Unintended Movement	13	13
Device Displays Incorrect Message	13	13
Deformation Due to Compressive Stress	12	12
Obstruction of Flow	12	12
Communication or Transmission Problem	11	11
Connection Problem	10	10
Activation Failure	9	9
Device Contamination with Body Fluid	9	9
Delivered as Unsterile Product	9	9
Signal Artifact/Noise	9	9
Physical Resistance/Sticking	8	8
Difficult to Open or Remove Packaging Material	8	8
Human-Device Interface Problem	8	8
Device Contaminated During Manufacture or Shipping	7	7
Difficult or Delayed Activation	7	7
Protective Measures Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3106	3106
Pericardial Effusion	441	441
Low Blood Pressure/ Hypotension	395	395
Stroke/CVA	266	266
Cardiac Tamponade	232	232
Non specific EKG/ECG Changes	191	191
Arrhythmia	146	146
Atrial Fibrillation	143	144
Unspecified Tissue Injury	129	129
Cardiac Arrest	121	121
Tachycardia	119	119
Heart Block	107	107
Cardiac Perforation	101	101
Vasoconstriction	81	81
Chest Pain	77	77
Bradycardia	73	73
Ischemia Stroke	72	72
Atrial Flutter	72	72
Ventricular Fibrillation	71	71
Hemorrhage/Bleeding	69	69
Syncope/Fainting	67	67
Hemolysis	66	66
Dyspnea	56	56
Pericarditis	55	55
Thrombosis/Thrombus	54	54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	48	48
Transient Ischemic Attack	44	44
Nerve Damage	43	43
Heart Failure/Congestive Heart Failure	40	40
Renal Failure	40	40
Asystole	38	38
Air Embolism	38	38
Hypoxia	29	29
Muscle Weakness	29	29
Hematuria	28	28
Perforation	28	28
Visual Disturbances	26	26
Hematoma	26	26
Pain	25	25
Myocardial Infarction	23	23
Urinary Retention	23	23
Insufficient Information	23	23
High Blood Pressure/ Hypertension	23	23
Cramp(s) /Muscle Spasm(s)	22	22
Embolism/Embolus	22	22
Speech Disorder	22	22
Numbness	21	21
Dizziness	20	20
Blurred Vision	19	19
Unspecified Kidney or Urinary Problem	19	19

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