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TPLC
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Device
catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Definition
For the treatment of atrial fibrillation.
Product Code
OAE
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
1
1
14
10
10
15
15
19
15
28
34
27
31
26
43
4
MDR Year
MDR Reports
MDR Events
2014
131
131
2015
274
274
2016
311
311
2017
387
387
2018
884
884
2019
908
908
2020
744
744
2021
914
914
2022
1162
1162
2023
1312
1312
2024
275
275
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3166
3166
Material Twisted/Bent
723
723
Material Integrity Problem
574
574
Optical Problem
361
361
Fluid/Blood Leak
343
343
Patient Device Interaction Problem
258
258
Device Contamination with Body Fluid
234
234
Communication or Transmission Problem
231
231
Insufficient Information
188
188
Fracture
172
172
Protective Measures Problem
160
160
Appropriate Term/Code Not Available
154
154
Material Deformation
135
135
Electrical Shorting
116
116
Kinked
100
100
Break
97
97
Gas/Air Leak
93
93
Device Displays Incorrect Message
82
82
Temperature Problem
77
77
Leak/Splash
75
75
Improper Flow or Infusion
70
70
Device Operates Differently Than Expected
70
70
Air Leak
59
59
Signal Artifact/Noise
52
52
Use of Device Problem
51
51
No Apparent Adverse Event
50
50
High impedance
47
47
Mechanical Problem
44
44
Obstruction of Flow
43
43
Incorrect, Inadequate or Imprecise Result or Readings
38
38
Display or Visual Feedback Problem
37
37
Compatibility Problem
33
33
Impedance Problem
30
30
Insufficient Cooling
30
30
Contamination /Decontamination Problem
21
21
Device Contamination with Chemical or Other Material
20
20
Coagulation in Device or Device Ingredient
20
20
Overheating of Device
20
20
Infusion or Flow Problem
19
19
Output Problem
17
17
Increase in Pressure
15
15
Off-Label Use
14
14
Material Rupture
14
14
Improper or Incorrect Procedure or Method
14
14
Material Puncture/Hole
12
12
Material Frayed
12
12
Intermittent Communication Failure
12
12
Failure to Deliver Energy
11
11
Difficult to Insert
11
11
Connection Problem
11
11
Failure to Sense
10
10
Positioning Problem
10
10
Data Problem
9
9
Defective Device
9
9
Device Sensing Problem
8
8
Device Handling Problem
8
8
Activation, Positioning or Separation Problem
7
7
Failure to Analyze Signal
7
7
Delivered as Unsterile Product
7
7
No Display/Image
7
7
Contamination
7
7
Entrapment of Device
6
6
Difficult To Position
6
6
Material Separation
6
6
Detachment of Device or Device Component
6
6
Difficult to Advance
6
6
Suction Problem
5
5
Insufficient Flow or Under Infusion
5
5
Deformation Due to Compressive Stress
5
5
Failure to Pump
5
5
Inflation Problem
5
5
Noise, Audible
5
5
Therapeutic or Diagnostic Output Failure
4
4
Unintended Electrical Shock
4
4
Image Display Error/Artifact
4
4
Flushing Problem
4
4
Deflation Problem
4
4
Thermal Decomposition of Device
4
4
Retraction Problem
4
4
Moisture Damage
4
4
Failure to Advance
4
4
Defective Component
4
4
Device Inoperable
4
4
Nonstandard Device
3
3
Failure to Deliver
3
3
Calibration Problem
3
3
Improper Device Output
3
3
Difficult to Remove
3
3
Electrical /Electronic Property Problem
3
3
Packaging Problem
3
3
Mechanics Altered
3
3
Moisture or Humidity Problem
2
2
Pressure Problem
2
2
Failure to Capture
2
2
Partial Blockage
2
2
Failure to Reset
2
2
Failure to Read Input Signal
2
2
Failure to Power Up
2
2
Poor Quality Image
2
2
Power Conditioning Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1941
1941
Cardiac Perforation
1155
1155
No Known Impact Or Consequence To Patient
900
900
Nerve Damage
744
745
No Consequences Or Impact To Patient
590
590
Pericardial Effusion
499
499
Cardiac Tamponade
393
393
Low Blood Pressure/ Hypotension
343
343
Stroke/CVA
223
223
Death
115
115
Fistula
97
97
ST Segment Elevation
87
87
Arrhythmia
80
80
Chest Pain
78
78
Hemorrhage/Bleeding
71
71
Heart Block
69
69
Cardiac Arrest
67
67
Dyspnea
65
65
Transient Ischemic Attack
63
63
Air Embolism
61
61
No Code Available
60
60
Thrombosis/Thrombus
59
59
Pericarditis
52
52
Tachycardia
52
52
Hematoma
51
51
Stenosis
49
49
Patient Problem/Medical Problem
49
49
Paresis
48
48
Thrombus
43
43
Inflammation
42
42
Pulmonary Valve Stenosis
39
39
Perforation
38
38
Bradycardia
38
38
Pseudoaneurysm
37
37
Hemoptysis
36
37
Perforation of Esophagus
35
35
Insufficient Information
34
34
Atrial Fibrillation
34
34
Paralysis
34
34
Atrial Flutter
33
33
Non specific EKG/ECG Changes
32
32
Blood Loss
31
31
Vascular Dissection
31
31
Embolism
29
29
Pain
29
29
Infarction, Cerebral
28
28
Fever
27
27
Pleural Effusion
25
25
Ventricular Fibrillation
25
25
Vomiting
25
25
Nausea
22
22
Tissue Damage
22
22
Heart Failure/Congestive Heart Failure
22
22
Myocardial Infarction
21
21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
20
20
Discomfort
19
19
Complete Heart Block
17
17
Embolism/Embolus
16
16
Hypoxia
16
17
Pneumothorax
15
15
No Information
15
15
Ischemia Stroke
14
14
Pulmonary Edema
14
14
Neurological Deficit/Dysfunction
13
13
Injury
12
12
High Blood Pressure/ Hypertension
12
12
No Patient Involvement
12
12
Laceration(s) of Esophagus
12
12
Vaso-Vagal Response
11
11
Exit Block
10
10
Loss of consciousness
10
10
Unspecified Tissue Injury
10
10
Bacterial Infection
10
10
Vasoconstriction
10
10
Muscle Weakness
10
10
Thrombosis
10
10
Pneumonia
9
9
Ventricular Tachycardia
9
9
Great Vessel Perforation
9
9
Pulmonary Embolism
9
9
Embolus
9
9
Fatigue
9
9
Intracranial Hemorrhage
8
8
Unspecified Infection
8
8
Dizziness
8
8
Peroneal Nerve Palsy
8
8
Sepsis
8
8
Cardiovascular Insufficiency
8
8
Gastroesophageal Burn
7
7
Hematuria
7
7
Respiratory Failure
7
7
Aortic Dissection
7
7
Headache
7
7
Abdominal Pain
7
7
Cardiopulmonary Arrest
6
6
Hemothorax
6
6
Ulcer
6
6
Blurred Vision
6
6
Perforation of Vessels
5
5
Ulceration
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott
II
Jul-07-2022
2
Abbott
II
Apr-19-2022
3
Abbott
II
Jul-10-2020
4
Abbott Laboratories Inc. (St Jude Medical)
II
Apr-09-2020
5
Biosense Webster, Inc.
II
May-28-2015
6
Biosense Webster, Inc.
II
Feb-07-2012
7
EPIX THERAPEUTICS, INC
II
Mar-29-2021
8
Medtronic Inc. Cardiac Rhythm Disease Management
II
Nov-02-2011
9
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
III
Mar-28-2019
10
St Jude Medical
II
Mar-17-2015
11
St. Jude Medical, Atrial Fibrillation Division, Inc.
II
Jan-25-2024
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