Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Definition For the treatment of atrial flutter.
Product CodeOAD
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
42 50 20 19 19 11

MDR Year MDR Reports MDR Events
2020 389 389
2021 402 402
2022 344 344
2023 319 319
2024 292 292
2025 70 70

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 462 462
Material Integrity Problem 250 250
Patient Device Interaction Problem 193 193
Fluid/Blood Leak 134 134
Temperature Problem 124 124
Device Displays Incorrect Message 92 92
Improper Flow or Infusion 54 54
Leak/Splash 50 50
Communication or Transmission Problem 47 47
Obstruction of Flow 43 43
Defective Device 40 40
Signal Artifact/Noise 39 39
Positioning Problem 33 33
Fracture 28 28
Poor Quality Image 25 25
Device Contamination with Chemical or Other Material 23 23
Break 20 20
Insufficient Cooling 19 19
Impedance Problem 19 19
Noise, Audible 18 18
Failure to Deliver Energy 18 18
Detachment of Device or Device Component 16 16
Material Perforation 16 16
Improper or Incorrect Procedure or Method 14 14
Data Problem 13 13
Mechanics Altered 13 13
Insufficient Flow or Under Infusion 13 13
Tear, Rip or Hole in Device Packaging 12 12
Output Problem 11 11
Mechanical Jam 11 11
High impedance 11 11
Material Twisted/Bent 11 11
Crack 10 10
Activation, Positioning or Separation Problem 10 10
Pressure Problem 10 10
Material Deformation 10 10
Device Contamination with Body Fluid 9 9
Failure to Sense 9 9
Overheating of Device 9 9
Connection Problem 9 9
Material Protrusion/Extrusion 9 9
Contamination 9 9
Power Conditioning Problem 9 9
Thermal Decomposition of Device 9 9
Device Remains Activated 8 8
Insufficient Information 8 8
No Apparent Adverse Event 8 8
Display or Visual Feedback Problem 7 7
Electrical Shorting 7 7
Entrapment of Device 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 906 906
Cardiac Perforation 166 166
Cardiac Tamponade 159 159
No Consequences Or Impact To Patient 157 157
Pericardial Effusion 76 76
No Known Impact Or Consequence To Patient 64 64
Heart Block 55 55
Stroke/CVA 50 50
Low Blood Pressure/ Hypotension 36 36
Arrhythmia 32 32
Nerve Damage 22 22
Fistula 19 19
Pseudoaneurysm 19 19
Thrombosis/Thrombus 19 19
Insufficient Information 19 19
Cardiac Arrest 18 18
Chest Pain 18 18
Hematoma 18 18
Air Embolism 15 15
Pericarditis 15 15
Death 14 14
Vascular Dissection 14 14
Transient Ischemic Attack 13 13
Tachycardia 13 13
Perforation of Esophagus 12 12
Stenosis 12 12
Atrial Fibrillation 11 11
Dyspnea 10 10
Hemorrhage/Bleeding 10 10
Paralysis 9 9
No Code Available 7 7
Embolism/Embolus 7 7
Ventricular Fibrillation 7 7
Complete Heart Block 7 7
Tissue Damage 7 7
Bradycardia 6 6
Myocardial Infarction 6 6
Pain 5 5
Thrombosis 5 5
Vasoconstriction 5 5
Unspecified Tissue Injury 5 5
Injury 5 5
Headache 5 5
Pulmonary Embolism 5 5
Cardiogenic Shock 4 4
Asystole 4 4
Burn(s) 4 4
Thrombus 4 4
Ischemia Stroke 4 4
Non specific EKG/ECG Changes 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Johnson & Johnson Surgical Vision, Inc. II Nov-02-2022
-
-