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)
2021	2022	2023	2024	2025	2026
0	0	1	16	40	6

MDR Year	MDR Reports	MDR Events
2024	1430	1431
2025	4131	4131
2026	377	377

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1959	1960
Entrapment of Device	814	814
Material Deformation	555	555
Material Twisted/Bent	553	553
Off-Label Use	476	476
Detachment of Device or Device Component	323	323
Material Integrity Problem	301	301
Device Contamination with Chemical or Other Material	253	253
Patient Device Interaction Problem	250	250
Improper Flow or Infusion	219	219
Fluid/Blood Leak	177	177
Positioning Failure	126	126
Contamination	111	111
Use of Device Problem	107	107
Air/Gas in Device	105	105
Break	105	105
Difficult to Flush	102	102
Difficult to Remove	101	101
Activation, Positioning or Separation Problem	98	98
Coagulation in Device or Device Ingredient	81	81
Nonstandard Device	75	75
Defective Device	63	63
Device-Device Incompatibility	46	46
Thermal Decomposition of Device	45	45
Restricted Flow rate	43	43
No Apparent Adverse Event	40	40
Tear, Rip or Hole in Device Packaging	37	37
Unsealed Device Packaging	35	35
Difficult to Advance	34	34
Packaging Problem	23	23
Mechanical Jam	20	20
Positioning Problem	17	17
Insufficient Information	16	16
Clumping in Device or Device Ingredient	15	15
Delivered as Unsterile Product	15	15
Obstruction of Flow	14	14
Device Displays Incorrect Message	14	14
Deformation Due to Compressive Stress	13	13
Unintended Movement	13	13
Communication or Transmission Problem	13	13
Human-Device Interface Problem	13	13
Activation Failure	12	12
Signal Artifact/Noise	10	10
Connection Problem	10	10
Difficult to Open or Remove Packaging Material	9	9
Device Contaminated During Manufacture or Shipping	9	9
Device Contamination with Body Fluid	9	9
Physical Resistance/Sticking	9	9
Output Problem	8	8
Difficult or Delayed Activation	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3274	3274
Pericardial Effusion	463	463
Low Blood Pressure/ Hypotension	423	423
Stroke/CVA	293	293
Cardiac Tamponade	250	250
Non specific EKG/ECG Changes	215	215
Arrhythmia	158	158
Atrial Fibrillation	153	154
Unspecified Tissue Injury	143	143
Cardiac Arrest	133	133
Heart Block	124	124
Tachycardia	123	123
Cardiac Perforation	110	110
Vasoconstriction	87	87
Chest Pain	85	85
Bradycardia	85	85
Ventricular Fibrillation	81	81
Syncope/Fainting	78	78
Ischemia Stroke	78	78
Atrial Flutter	76	76
Hemorrhage/Bleeding	76	76
Hemolysis	72	72
Dyspnea	63	63
Pericarditis	58	58
Thrombosis/Thrombus	54	54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	50	50
Transient Ischemic Attack	50	50
Heart Failure/Congestive Heart Failure	49	49
Nerve Damage	48	48
Asystole	43	43
Renal Failure	43	43
Air Embolism	39	39
Muscle Weakness	34	34
Hypoxia	32	32
Hematoma	32	32
Perforation	29	29
Hematuria	28	28
Insufficient Information	27	27
Pain	27	27
Visual Disturbances	27	27
Dizziness	26	26
Cramp(s) /Muscle Spasm(s)	26	26
Embolism/Embolus	24	24
High Blood Pressure/ Hypertension	24	24
Myocardial Infarction	24	24
Urinary Retention	23	23
Speech Disorder	22	22
Numbness	21	21
Paralysis	20	20
Blurred Vision	20	20

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