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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, intracardiac mapping, high-density array
Product CodeMTD
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSENSE WEBSTER INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 3
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 1
STERILMED INC. (JOHNSON AND JOHNSON)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 77 77
2020 87 87
2021 99 99
2022 145 145
2023 184 184
2024 155 155

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 206 206
Adverse Event Without Identified Device or Use Problem 84 84
Entrapment of Device 80 80
Obstruction of Flow 70 70
Device Contamination with Body Fluid 65 65
Detachment of Device or Device Component 60 60
Contamination /Decontamination Problem 54 54
Signal Artifact/Noise 49 49
Coagulation in Device or Device Ingredient 41 41
Material Twisted/Bent 41 41
Material Protrusion/Extrusion 37 37
Device-Device Incompatibility 35 35
Sharp Edges 27 27
Break 26 26
Material Separation 19 19
Display or Visual Feedback Problem 18 18
Complete Blockage 17 17
Material Deformation 16 16
Mechanical Jam 13 13
Tear, Rip or Hole in Device Packaging 11 11
Communication or Transmission Problem 9 9
Positioning Problem 9 9
Manufacturing, Packaging or Shipping Problem 7 7
Packaging Problem 6 6
Delivered as Unsterile Product 5 5
Off-Label Use 4 4
Electrical Shorting 4 4
Failure to Advance 4 4
Improper or Incorrect Procedure or Method 4 4
Separation Problem 4 4
Appropriate Term/Code Not Available 4 4
Material Split, Cut or Torn 3 3
Therapeutic or Diagnostic Output Failure 3 3
Application Program Problem 3 3
Partial Blockage 3 3
Contamination 2 2
Material Too Rigid or Stiff 2 2
Failure to Sense 2 2
Fracture 2 2
Material Fragmentation 2 2
Device Contamination with Chemical or Other Material 2 2
Device Sensing Problem 2 2
Gas/Air Leak 1 1
Electromagnetic Compatibility Problem 1 1
Component Missing 1 1
Failure to Unfold or Unwrap 1 1
Use of Device Problem 1 1
Material Frayed 1 1
Fluid/Blood Leak 1 1
Difficult to Remove 1 1
No Display/Image 1 1
Device Alarm System 1 1
Protective Measures Problem 1 1
Physical Resistance/Sticking 1 1
Material Integrity Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 382 382
Cardiac Tamponade 106 106
No Consequences Or Impact To Patient 71 71
Foreign Body In Patient 53 53
No Code Available 29 29
Cardiac Perforation 23 23
Cardiac Arrest 20 20
Stroke/CVA 12 12
Air Embolism 12 12
Ischemic Heart Disease 11 11
Thrombosis/Thrombus 9 9
Rupture 7 7
Transient Ischemic Attack 6 6
Pericardial Effusion 6 6
Insufficient Information 5 5
Heart Block 5 5
Device Embedded In Tissue or Plaque 5 5
Ventricular Fibrillation 5 5
Perforation of Vessels 4 4
Hematoma 4 4
Low Blood Pressure/ Hypotension 4 4
No Known Impact Or Consequence To Patient 4 4
Unspecified Tissue Injury 4 4
Paralysis 3 3
Death 3 3
Arrhythmia 3 3
Tachycardia 3 3
Pseudoaneurysm 3 3
Complete Heart Block 2 2
Cardiogenic Shock 2 2
Thrombosis 2 2
Urinary Tract Infection 2 2
Vasoconstriction 2 2
Ventricular Tachycardia 2 2
Bradycardia 2 2
Hemorrhage/Bleeding 2 2
Pneumothorax 2 2
Myocardial Infarction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Vascular Dissection 1 1
Heart Failure/Congestive Heart Failure 1 1
Pericarditis 1 1
Nerve Damage 1 1
Mitral Insufficiency 1 1
Mitral Regurgitation 1 1
Pulmonary Embolism 1 1
Pleural Effusion 1 1
Anemia 1 1
Aortic Insufficiency 1 1
Visual Impairment 1 1
Thromboembolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Jun-01-2022
2 BIOSENSE WEBSTER II Jun-16-2020
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