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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
Regulation Description Electrode recording catheter or electrode recording probe.
Product CodeMTD
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
  1.  K153093  FIRMap Catheter
  2.  K163709  FIRMap Catheter
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 2
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (ABBOTT LABORATORIES)
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 96 96
Entrapment of Device 38 38
Detachment of Device or Device Component 25 25
Sharp Edges 24 24
Coagulation in Device or Device Ingredient 23 23
Contamination /Decontamination Problem 10 10
Material Deformation 8 8
Device Displays Incorrect Message 8 8
Break 8 8
Catheter 8 8
Bent 7 7
Difficult to Remove 7 7
Device Operates Differently Than Expected 6 6
Material Twisted/Bent 6 6
Device Contamination with Chemical or Other Material 6 6
Insufficient Information 5 5
Physical Resistance 5 5
Signal Artifact/Noise 5 5
Appropriate Term/Code Not Available 4 4
Tip 4 4
Noise, Audible 4 4
Patient Device Interaction Problem 4 4
Material Split, Cut or Torn 4 4
Sticking 4 4
Material Frayed 4 4
Sensor 3 3
Device Inoperable 3 3
Scratched Material 3 3
Material Protrusion/Extrusion 3 3
No Display/Image 3 3
Material Separation 3 3
Device Issue 3 3
Use of Device Problem 2 2
Fracture 2 2
Material Fragmentation 2 2
Hole In Material 2 2
Electrode 2 2
Therapeutic or Diagnostic Output Failure 2 2
Separation Problem 2 2
Device Sensing Problem 2 2
Device-Device Incompatibility 2 2
Occlusion Within Device 2 2
Device Contamination with Body Fluid 2 2
Tear, Rip or Hole in Device Packaging 2 2
Detachment Of Device Component 2 2
Disconnection 1 1
Valve(s) 1 1
Inability to Irrigate 1 1
Kinked 1 1
Ambient Noise Problem 1 1
Material Rupture 1 1
Failure to Read Input Signal 1 1
Improper or Incorrect Procedure or Method 1 1
Electromagnetic Compatibility Problem 1 1
Positioning Problem 1 1
No Flow 1 1
Physical Property Issue 1 1
Device Handling Problem 1 1
Tube 1 1
Ring 1 1
Air Leak 1 1
Complete Blockage 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Puncture/Hole 1 1
Display or Visual Feedback Problem 1 1
False Reading From Device Non-Compliance 1 1
Fluid Leak 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Stretched 1 1
Failure to Unfold or Unwrap 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Failure to Sense 1 1
Defective Device 1 1
Folded 1 1
Communication or Transmission Problem 1 1
Device Packaging Compromised 1 1
Device Dislodged or Dislocated 1 1
Gas Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 109 109
Cardiac Tamponade 43 43
No Code Available 43 43
No Known Impact Or Consequence To Patient 25 25
Cardiac Perforation 22 22
Low Blood Pressure/ Hypotension 15 15
No Clinical Signs, Symptoms or Conditions 14 14
Foreign Body In Patient 11 11
Cardiac Arrest 7 7
Pericardial Effusion 7 7
Stroke/CVA 6 6
Device Embedded In Tissue or Plaque 6 6
Death 5 5
Air Embolism 5 5
Thrombosis 4 4
No Information 4 4
Ventricular Fibrillation 3 3
Transient Ischemic Attack 3 3
Rupture 3 3
Hematoma 3 3
Vascular Dissection 3 3
Complete Heart Block 2 2
ST Segment Elevation 2 2
Ventricular Tachycardia 2 2
Arrhythmia 2 2
Atrial Fibrillation 2 2
Injury 2 2
Bradycardia 1 1
Cardiogenic Shock 1 1
Pseudoaneurysm 1 1
No Patient Involvement 1 1
Hemorrhage/Bleeding 1 1
Mitral Insufficiency 1 1
Myocardial Infarction 1 1
Pain 1 1
Paralysis 1 1
Urinary Tract Infection 1 1
Vasoconstriction 1 1
Thrombus 1 1
Pulmonary Embolism 1 1
Mitral Regurgitation 1 1
Perforation 1 1
Aortic Insufficiency 1 1
Burn(s) 1 1
Endocarditis 1 1
Insufficient Information 1 1
Physical Entrapment 1 1

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