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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
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERILMED INC. (JOHNSON AND JOHNSON)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 49 49
2019 77 77
2020 87 87
2021 99 99
2022 145 145
2023 149 149

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 170 170
Adverse Event Without Identified Device or Use Problem 98 98
Entrapment of Device 81 81
Detachment of Device or Device Component 62 62
Device Contamination with Body Fluid 52 52
Contamination /Decontamination Problem 42 42
Signal Artifact/Noise 34 34
Coagulation in Device or Device Ingredient 31 31
Material Protrusion/Extrusion 31 31
Material Twisted/Bent 30 30
Sharp Edges 30 30
Device-Device Incompatibility 29 29
Break 20 20
Material Deformation 18 18
Complete Blockage 16 16
Material Separation 16 16
Display or Visual Feedback Problem 14 14
Mechanical Jam 9 9
Positioning Problem 7 7
Tear, Rip or Hole in Device Packaging 7 7
Communication or Transmission Problem 5 5
Delivered as Unsterile Product 5 5
Separation Problem 5 5
Material Split, Cut or Torn 4 4
Appropriate Term/Code Not Available 4 4
Material Frayed 4 4
Partial Blockage 3 3
Device Displays Incorrect Message 3 3
Application Program Problem 3 3
Device Issue 3 3
Use of Device Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Contamination with Chemical or Other Material 3 3
Device Sensing Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Packaging Problem 2 2
Difficult to Remove 2 2
Material Too Rigid or Stiff 2 2
Physical Resistance 2 2
Contamination 2 2
No Display/Image 2 2
Bent 2 2
Hole In Material 2 2
Off-Label Use 2 2
Fluid/Blood Leak 2 2
Fracture 2 2
Material Fragmentation 2 2
Material Puncture/Hole 1 1
Inability to Irrigate 1 1
Defective Device 1 1
Obstruction of Flow 1 1
Failure to Advance 1 1
Failure to Sense 1 1
Stretched 1 1
Failure to Unfold or Unwrap 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Output Problem 1 1
No Flow 1 1
Electrical Shorting 1 1
Electromagnetic Compatibility Problem 1 1
Gas/Air Leak 1 1
Material Integrity Problem 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 229 229
No Consequences Or Impact To Patient 95 95
Cardiac Tamponade 93 93
Foreign Body In Patient 49 49
No Code Available 38 38
Cardiac Perforation 24 24
Cardiac Arrest 18 18
Stroke/CVA 13 13
Air Embolism 12 12
Ischemic Heart Disease 9 9
Thrombosis/Thrombus 8 8
No Known Impact Or Consequence To Patient 7 7
Rupture 7 7
Transient Ischemic Attack 7 7
Device Embedded In Tissue or Plaque 5 5
Pericardial Effusion 5 5
Insufficient Information 5 5
Unspecified Tissue Injury 4 4
Ventricular Fibrillation 4 4
Hematoma 4 4
Low Blood Pressure/ Hypotension 4 4
Paralysis 3 3
Tachycardia 3 3
Death 3 3
Arrhythmia 3 3
Pseudoaneurysm 3 3
Heart Block 3 3
Vascular Dissection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Complete Heart Block 2 2
Cardiogenic Shock 2 2
Ventricular Tachycardia 2 2
Perforation of Vessels 2 2
Urinary Tract Infection 2 2
Vasoconstriction 2 2
Bradycardia 2 2
Hemorrhage/Bleeding 2 2
Thrombosis 2 2
Myocardial Infarction 2 2
Nerve Damage 1 1
Mitral Insufficiency 1 1
Mitral Regurgitation 1 1
Thrombus 1 1
Pleural Effusion 1 1
Pneumothorax 1 1
Anemia 1 1
Aortic Insufficiency 1 1
Visual Impairment 1 1
Pulmonary Embolism 1 1
Thromboembolism 1 1
No Information 1 1
Heart Failure/Congestive Heart Failure 1 1
Pericarditis 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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