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TPLC
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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
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