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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Definition For the treatment of atrial fibrillation.
Product CodeOAE
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
34 27 31 26 43 9

MDR Year MDR Reports MDR Events
2019 908 908
2020 744 744
2021 914 914
2022 1162 1162
2023 1312 1312
2024 471 471

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2374 2374
Material Twisted/Bent 649 649
Material Integrity Problem 455 455
Optical Problem 352 352
Patient Device Interaction Problem 285 285
Fluid/Blood Leak 227 227
Device Contamination with Body Fluid 223 223
Communication or Transmission Problem 209 209
Fracture 172 172
Protective Measures Problem 169 169
Electrical Shorting 116 116
Material Deformation 81 81
Gas/Air Leak 80 80
Improper Flow or Infusion 68 68
Temperature Problem 66 66
Break 66 66
Incorrect, Inadequate or Imprecise Result or Readings 53 53
Leak/Splash 51 51
Signal Artifact/Noise 50 50
Obstruction of Flow 46 46
Mechanical Problem 45 45
No Apparent Adverse Event 45 45
Use of Device Problem 44 44
High impedance 41 41
Display or Visual Feedback Problem 38 38
Insufficient Cooling 36 36
Compatibility Problem 34 34
Impedance Problem 27 27
Contamination /Decontamination Problem 27 27
Coagulation in Device or Device Ingredient 25 25
Appropriate Term/Code Not Available 22 22
Infusion or Flow Problem 20 20
Overheating of Device 19 19
Device Displays Incorrect Message 18 18
Increase in Pressure 17 17
Device Contamination with Chemical or Other Material 17 17
Output Problem 16 16
Insufficient Information 15 15
Off-Label Use 14 14
Material Frayed 12 12
Intermittent Communication Failure 12 12
Material Puncture/Hole 11 11
Failure to Deliver Energy 10 10
Entrapment of Device 9 9
Failure to Sense 9 9
Connection Problem 8 8
Difficult to Insert 8 8
Data Problem 8 8
Device Handling Problem 8 8
Defective Device 8 8
Device Sensing Problem 8 8
Activation, Positioning or Separation Problem 7 7
Failure to Analyze Signal 7 7
Improper or Incorrect Procedure or Method 7 7
Insufficient Flow or Under Infusion 7 7
Failure to Pump 7 7
Detachment of Device or Device Component 6 6
Delivered as Unsterile Product 6 6
Contamination 5 5
Material Separation 5 5
Positioning Problem 5 5
Unintended Electrical Shock 4 4
Flushing Problem 4 4
Thermal Decomposition of Device 4 4
Image Display Error/Artifact 3 3
Calibration Problem 3 3
Difficult to Remove 3 3
Therapeutic or Diagnostic Output Failure 3 3
Mechanical Jam 3 3
Mechanics Altered 3 3
Packaging Problem 2 2
Device-Device Incompatibility 2 2
Output below Specifications 2 2
Failure to Advance 2 2
Defective Component 2 2
Inaccurate Delivery 2 2
Failure to Power Up 2 2
Inflation Problem 2 2
Energy Output Problem 2 2
No Device Output 2 2
Poor Quality Image 2 2
Electrical /Electronic Property Problem 2 2
Device Alarm System 1 1
False Alarm 1 1
Positioning Failure 1 1
Unintended Power Up 1 1
Failure to Discharge 1 1
Erratic or Intermittent Display 1 1
No Display/Image 1 1
Nonstandard Device 1 1
Inadequate Instructions for Healthcare Professional 1 1
Excess Flow or Over-Infusion 1 1
Image Orientation Incorrect 1 1
Insufficient Heating 1 1
Material Fragmentation 1 1
Peeled/Delaminated 1 1
Power Conditioning Problem 1 1
Failure to Transmit Record 1 1
Device Remains Activated 1 1
Unstable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2039 2039
Cardiac Perforation 862 862
Nerve Damage 522 522
No Consequences Or Impact To Patient 396 396
No Known Impact Or Consequence To Patient 380 380
Cardiac Tamponade 303 303
Pericardial Effusion 289 289
Stroke/CVA 190 190
Low Blood Pressure/ Hypotension 183 183
Heart Block 74 74
Arrhythmia 64 64
Thrombosis/Thrombus 63 63
Chest Pain 56 56
Pericarditis 55 55
Hemorrhage/Bleeding 52 52
Fistula 48 48
Cardiac Arrest 48 48
Transient Ischemic Attack 46 46
Tachycardia 45 45
Death 44 44
Patient Problem/Medical Problem 38 38
Dyspnea 37 37
Perforation of Esophagus 37 37
Non specific EKG/ECG Changes 35 35
Inflammation 35 35
Insufficient Information 34 34
Stenosis 33 33
Pseudoaneurysm 32 32
Thrombus 31 31
Atrial Fibrillation 31 31
Atrial Flutter 31 31
Air Embolism 29 29
Hematoma 28 28
Hemoptysis 24 24
Paresis 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Heart Failure/Congestive Heart Failure 24 24
Vascular Dissection 23 23
ST Segment Elevation 23 23
Pulmonary Valve Stenosis 22 22
Perforation 22 22
Pain 22 22
Embolism 21 21
Paralysis 18 18
Embolism/Embolus 18 18
Tissue Damage 17 17
Ventricular Fibrillation 16 16
Pleural Effusion 16 16
Bradycardia 16 16
No Code Available 16 16
Ischemia Stroke 14 14
Fever 14 14
Vomiting 14 14
Pulmonary Edema 13 13
Nausea 12 12
Myocardial Infarction 11 11
Hypoxia 11 11
Complete Heart Block 11 11
Unspecified Tissue Injury 11 11
Cardiovascular Insufficiency 10 10
Muscle Weakness 9 9
Intracranial Hemorrhage 8 8
Bacterial Infection 8 8
Pneumothorax 8 8
Great Vessel Perforation 8 8
Discomfort 8 8
Dizziness 8 8
Blood Loss 8 8
Exit Block 7 7
No Patient Involvement 7 7
Gastroesophageal Burn 7 7
Swelling/ Edema 7 7
Laceration(s) of Esophagus 7 7
Sepsis 7 7
Pneumonia 7 7
High Blood Pressure/ Hypertension 7 7
Unspecified Infection 6 6
Embolus 6 6
Cough 6 6
Syncope/Fainting 6 6
Unspecified Nervous System Problem 5 5
Unspecified Gastrointestinal Problem 5 5
Infarction, Cerebral 5 5
Pulmonary Embolism 5 5
Abdominal Pain 5 5
Hemothorax 5 5
Fatigue 5 5
Vasoconstriction 5 5
Visual Disturbances 5 5
Respiratory Failure 5 5
Obstruction/Occlusion 5 5
Loss of consciousness 4 4
Ventricular Tachycardia 4 4
Perforation of Vessels 4 4
Blurred Vision 4 4
Headache 4 4
Hypersensitivity/Allergic reaction 4 4
Laceration(s) 4 4
Neurological Deficit/Dysfunction 4 4
Cardiomyopathy 4 4

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 EPIX THERAPEUTICS, INC II Mar-29-2021
6 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) III Mar-28-2019
7 St. Jude Medical, Atrial Fibrillation Division, Inc. II Jan-25-2024
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