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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device catheter, intracardiac mapping, high-density array
Product CodeMTD
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT ELECTROPHYSIOLOGY
  SUBSTANTIALLY EQUIVALENT 2
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOSENSE WEBSTER, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
2016 35 35
2017 38 38
2018 49 49
2019 77 77
2020 87 87
2021 99 99
2022 84 84

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 105 105
Patient Device Interaction Problem 83 83
Entrapment of Device 69 69
Detachment of Device or Device Component 50 50
Sharp Edges 30 30
Contamination /Decontamination Problem 27 27
Coagulation in Device or Device Ingredient 23 23
Device Contamination with Body Fluid 21 21
Signal Artifact/Noise 19 19
Material Twisted/Bent 17 17
Material Protrusion/Extrusion 14 14
Break 14 14
Material Deformation 13 13
Complete Blockage 11 11
Material Separation 9 9
Device-Device Incompatibility 9 9
Device Displays Incorrect Message 8 8
Difficult to Remove 7 7
Bent 7 7
Device Contamination with Chemical or Other Material 6 6
Device Operates Differently Than Expected 6 6
Tear, Rip or Hole in Device Packaging 5 5
Physical Resistance 5 5
Insufficient Information 5 5
Appropriate Term/Code Not Available 5 5
Noise, Audible 4 4
Material Split, Cut or Torn 4 4
Display or Visual Feedback Problem 4 4
Material Frayed 4 4
Sticking 4 4
Device Inoperable 3 3
Device Issue 3 3
Use of Device Problem 3 3
Partial Blockage 3 3
No Display/Image 3 3
Separation Problem 3 3
Mechanical Jam 3 3
Positioning Problem 3 3
Scratched Material 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Sensing Problem 2 2
Communication or Transmission Problem 2 2
Detachment Of Device Component 2 2
Hole In Material 2 2
Fracture 2 2
Material Fragmentation 2 2
Occlusion Within Device 2 2
Material Too Rigid or Stiff 2 2
Material Rupture 1 1
Failure to Sense 1 1
Failure to Read Input Signal 1 1
Material Puncture/Hole 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Failure to Unfold or Unwrap 1 1
Stretched 1 1
False Reading From Device Non-Compliance 1 1
Fluid Leak 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inability to Irrigate 1 1
Kinked 1 1
Delivered as Unsterile Product 1 1
Disconnection 1 1
Air Leak 1 1
Folded 1 1
Ambient Noise Problem 1 1
Defective Device 1 1
Obstruction of Flow 1 1
Device Packaging Compromised 1 1
Gas Leak 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Dislodged or Dislocated 1 1
Electromagnetic Compatibility Problem 1 1
Physical Property Issue 1 1
No Flow 1 1
Material Integrity Problem 1 1
Physical Resistance/Sticking 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 109 109
No Clinical Signs, Symptoms or Conditions 97 97
Cardiac Tamponade 74 74
No Code Available 43 43
Foreign Body In Patient 33 33
Cardiac Perforation 28 28
No Known Impact Or Consequence To Patient 25 25
Low Blood Pressure/ Hypotension 15 15
Cardiac Arrest 13 13
Stroke/CVA 13 13
Pericardial Effusion 8 8
Air Embolism 7 7
Rupture 7 7
Ventricular Fibrillation 6 6
Device Embedded In Tissue or Plaque 6 6
Transient Ischemic Attack 5 5
Death 5 5
Arrhythmia 4 4
Hematoma 4 4
Thrombosis 4 4
No Information 4 4
Thrombosis/Thrombus 4 4
Insufficient Information 3 3
Vascular Dissection 3 3
Pseudoaneurysm 3 3
Cardiogenic Shock 3 3
Hemorrhage/Bleeding 3 3
Myocardial Infarction 3 3
Atrial Fibrillation 2 2
Injury 2 2
Ischemic Heart Disease 2 2
Ventricular Tachycardia 2 2
Urinary Tract Infection 2 2
Paralysis 2 2
ST Segment Elevation 2 2
Complete Heart Block 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Pulmonary Embolism 2 2
Heart Block 2 2
Heart Failure/Congestive Heart Failure 1 1
No Patient Involvement 1 1
Thromboembolism 1 1
Tachycardia 1 1
Perforation 1 1
Pneumothorax 1 1
Vasoconstriction 1 1
Thrombus 1 1
Physical Entrapment 1 1
Bradycardia 1 1
Burn(s) 1 1
Endocarditis 1 1
Nerve Damage 1 1
Pain 1 1
Mitral Insufficiency 1 1
Mitral Regurgitation 1 1
Aortic Insufficiency 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Jun-01-2022
2 BIOSENSE WEBSTER II Jun-16-2020
3 Biosense Webster, Inc. II Dec-07-2017
4 Biosense Webster, Inc. II Apr-29-2016
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