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TPLC
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show TPLC since
2009
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2024
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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)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
11
MDR Year
MDR Reports
MDR Events
2024
805
805
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
253
253
Entrapment of Device
154
154
Detachment of Device or Device Component
100
100
Material Twisted/Bent
71
71
Material Deformation
53
53
Off-Label Use
52
52
Material Integrity Problem
48
48
Positioning Failure
42
42
Improper Flow or Infusion
36
36
Fluid/Blood Leak
35
35
Activation, Positioning or Separation Problem
26
26
Device Contamination with Chemical or Other Material
25
25
Difficult to Flush
20
20
Defective Device
19
19
Use of Device Problem
16
16
Difficult to Remove
15
15
Air/Gas in Device
12
12
Device-Device Incompatibility
5
5
Thermal Decomposition of Device
4
4
Leak/Splash
3
3
Coagulation in Device or Device Ingredient
3
3
Break
3
3
Unsealed Device Packaging
3
3
Positioning Problem
3
3
Contamination
3
3
Power Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Packaging Problem
2
2
Obstruction of Flow
2
2
Signal Artifact/Noise
2
2
Difficult to Insert
1
1
Insufficient Information
1
1
Unintended Movement
1
1
Difficult to Advance
1
1
Image Display Error/Artifact
1
1
Difficult to Open or Remove Packaging Material
1
1
Communication or Transmission Problem
1
1
Device Contamination with Body Fluid
1
1
Separation Problem
1
1
Unexpected Shutdown
1
1
Device Contaminated During Manufacture or Shipping
1
1
No Apparent Adverse Event
1
1
Compatibility Problem
1
1
Fitting Problem
1
1
Connection Problem
1
1
Electrical /Electronic Property Problem
1
1
Device Displays Incorrect Message
1
1
Arcing of Electrodes
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
509
509
Pericardial Effusion
48
48
Low Blood Pressure/ Hypotension
42
42
Cardiac Tamponade
30
30
Atrial Fibrillation
29
29
Syncope/Fainting
28
28
Unspecified Tissue Injury
24
24
Arrhythmia
18
18
Atrial Flutter
17
17
Non specific EKG/ECG Changes
14
14
Tachycardia
12
12
Stroke/CVA
12
12
Dyspnea
11
11
Cardiac Perforation
11
11
Renal Failure
9
9
Bradycardia
9
9
Chest Pain
9
9
Vasoconstriction
9
9
Hemolysis
9
9
Heart Block
8
8
Cardiac Arrest
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Ischemia Stroke
5
5
Respiratory Insufficiency
4
4
Hemorrhage/Bleeding
4
4
Pericarditis
4
4
Thrombosis/Thrombus
4
4
Air Embolism
3
3
Hematuria
3
3
Heart Failure/Congestive Heart Failure
3
3
Swelling/ Edema
3
3
Urinary Retention
3
3
Pleural Effusion
3
3
Transient Ischemic Attack
3
3
Nerve Damage
3
3
Fever
3
3
Hypoxia
3
3
Ventricular Fibrillation
3
3
Visual Disturbances
3
3
Electric Shock
3
3
Pulmonary Edema
2
2
Asystole
2
2
High Blood Pressure/ Hypertension
2
2
Unspecified Kidney or Urinary Problem
2
2
Renal Impairment
2
2
Vomiting
2
2
Pneumothorax
2
2
Paralysis
2
2
Intracranial Hemorrhage
2
2
Myocardial Infarction
2
2
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