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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 22

MDR Year MDR Reports MDR Events
2019 908 908
2020 744 744
2021 914 914
2022 1162 1162
2023 1312 1312
2024 1383 1383

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2601 2601
Material Twisted/Bent 721 721
Material Integrity Problem 491 491
Patient Device Interaction Problem 400 400
Optical Problem 371 371
Device Contamination with Body Fluid 354 354
Communication or Transmission Problem 235 235
Fluid/Blood Leak 234 234
Protective Measures Problem 204 204
Fracture 186 186
Incorrect, Inadequate or Imprecise Result or Readings 118 118
Electrical Shorting 117 117
Gas/Air Leak 101 101
Material Deformation 98 98
Temperature Problem 90 90
Coagulation in Device or Device Ingredient 81 81
Improper Flow or Infusion 75 75
Insufficient Cooling 72 72
Signal Artifact/Noise 68 68
Break 67 67
Mechanical Problem 62 62
Obstruction of Flow 61 61
Use of Device Problem 60 60
Contamination /Decontamination Problem 60 60
Leak/Splash 53 53
No Apparent Adverse Event 46 46
Display or Visual Feedback Problem 46 46
High impedance 44 44
Compatibility Problem 43 43
Overheating of Device 34 34
Failure to Sense 31 31
Impedance Problem 31 31
Infusion or Flow Problem 30 30
Appropriate Term/Code Not Available 26 26
Increase in Pressure 24 24
Device Contamination with Chemical or Other Material 20 20
Insufficient Information 19 19
Device Displays Incorrect Message 19 19
Off-Label Use 19 19
Output Problem 16 16
Device Handling Problem 15 15
Failure to Pump 15 15
Defective Device 14 14
Entrapment of Device 14 14
Excessive Cooling 13 13
Improper or Incorrect Procedure or Method 12 12
Material Frayed 12 12
Device Sensing Problem 12 12
Intermittent Communication Failure 12 12
Material Puncture/Hole 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2603 2603
Cardiac Perforation 938 938
Nerve Damage 574 574
No Consequences Or Impact To Patient 396 396
Cardiac Tamponade 386 386
No Known Impact Or Consequence To Patient 380 380
Pericardial Effusion 312 312
Low Blood Pressure/ Hypotension 213 213
Stroke/CVA 210 210
Heart Block 87 87
Arrhythmia 77 77
Thrombosis/Thrombus 69 69
Pericarditis 67 67
Chest Pain 61 61
Hemorrhage/Bleeding 61 61
Fistula 58 58
Cardiac Arrest 54 54
Transient Ischemic Attack 51 51
Tachycardia 48 48
Non specific EKG/ECG Changes 45 45
Death 44 44
Insufficient Information 43 43
Stenosis 42 42
Dyspnea 40 40
Inflammation 39 39
Patient Problem/Medical Problem 38 38
Perforation of Esophagus 38 38
Atrial Fibrillation 37 37
Pseudoaneurysm 36 36
Atrial Flutter 35 35
Hematoma 33 33
Thrombus 31 31
Air Embolism 30 30
Paresis 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Heart Failure/Congestive Heart Failure 26 26
Hemoptysis 26 26
Pulmonary Valve Stenosis 25 25
Embolism/Embolus 24 24
Perforation 24 24
Vascular Dissection 24 24
ST Segment Elevation 23 23
Pain 22 22
Embolism 21 21
Paralysis 19 19
Pleural Effusion 18 18
Ventricular Fibrillation 18 18
Bradycardia 17 17
Vomiting 17 17
Tissue Damage 17 17

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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