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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
10
MDR Year
MDR Reports
MDR Events
2024
1430
1431
2025
4131
4131
2026
787
787
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2110
2111
Entrapment of Device
846
846
Material Deformation
599
599
Material Twisted/Bent
582
582
Off-Label Use
489
489
Detachment of Device or Device Component
331
331
Material Integrity Problem
303
303
Patient Device Interaction Problem
276
276
Device Contamination with Chemical or Other Material
264
264
Improper Flow or Infusion
219
219
Fluid/Blood Leak
191
191
Contamination
158
158
Positioning Failure
126
126
Difficult to Flush
121
121
Use of Device Problem
115
115
Break
112
112
Air/Gas in Device
108
108
Difficult to Remove
107
107
Activation, Positioning or Separation Problem
100
100
Nonstandard Device
94
94
Coagulation in Device or Device Ingredient
84
84
Defective Device
64
64
Restricted Flow rate
53
53
Device-Device Incompatibility
48
48
Thermal Decomposition of Device
47
47
No Apparent Adverse Event
46
46
Tear, Rip or Hole in Device Packaging
38
38
Unsealed Device Packaging
35
35
Difficult to Advance
35
35
Packaging Problem
23
23
Mechanical Jam
22
22
Delivered as Unsterile Product
21
21
Communication or Transmission Problem
19
19
Positioning Problem
18
18
Insufficient Information
17
17
Clumping in Device or Device Ingredient
16
16
Activation Failure
15
15
Human-Device Interface Problem
15
15
Device Displays Incorrect Message
15
15
Obstruction of Flow
14
14
Physical Resistance/Sticking
13
13
Deformation Due to Compressive Stress
13
13
Unintended Movement
13
13
High Readings
12
12
Signal Artifact/Noise
12
12
Output Problem
12
12
Device Contaminated During Manufacture or Shipping
11
11
Connection Problem
11
11
Therapeutic or Diagnostic Output Failure
10
10
Device Sensing Problem
10
10
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3496
3496
Pericardial Effusion
494
494
Low Blood Pressure/ Hypotension
462
462
Stroke/CVA
316
316
Cardiac Tamponade
270
270
Non specific EKG/ECG Changes
232
232
Atrial Fibrillation
164
165
Arrhythmia
163
163
Unspecified Tissue Injury
149
149
Cardiac Arrest
147
147
Tachycardia
134
134
Heart Block
132
132
Cardiac Perforation
115
115
Bradycardia
94
94
Chest Pain
92
92
Ventricular Fibrillation
90
90
Vasoconstriction
89
89
Hemorrhage/Bleeding
87
87
Syncope/Fainting
81
81
Ischemia Stroke
80
80
Atrial Flutter
78
78
Hemolysis
76
76
Dyspnea
71
71
Pericarditis
60
60
Thrombosis/Thrombus
57
57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
56
56
Transient Ischemic Attack
54
54
Heart Failure/Congestive Heart Failure
51
51
Nerve Damage
48
48
Renal Failure
45
45
Asystole
45
45
Air Embolism
44
44
Muscle Weakness
35
35
Hypoxia
34
34
Hematoma
33
33
Dizziness
32
32
Insufficient Information
31
31
Hematuria
30
30
Perforation
30
30
Pain
27
27
Visual Disturbances
27
27
High Blood Pressure/ Hypertension
27
27
Cramp(s) /Muscle Spasm(s)
27
27
Embolism/Embolus
24
24
Myocardial Infarction
24
24
Urinary Retention
24
24
Speech Disorder
23
23
Blurred Vision
22
22
Numbness
22
22
Paralysis
21
21
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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