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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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 95 95
Entrapment of Device 34 34
Detachment of Device or Device Component 24 24
Coagulation in Device or Device Ingredient 23 23
Sharp Edges 23 23
Contamination /Decontamination Problem 10 10
Device Displays Incorrect Message 8 8
Catheter 8 8
Bent 7 7
Break 7 7
Difficult to Remove 7 7
Material Deformation 7 7
Device Contamination with Chemical or Other Material 6 6
Device Operates Differently Than Expected 6 6
Physical Resistance 5 5
Insufficient Information 5 5
Appropriate Term/Code Not Available 4 4
Tip 4 4
Noise, Audible 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
Device Issue 3 3
Signal Artifact/Noise 3 3
Material Protrusion/Extrusion 3 3
Material Twisted/Bent 3 3
No Display/Image 3 3
Electrode 2 2
Fracture 2 2
Material Fragmentation 2 2
Hole In Material 2 2
Material Separation 2 2
Use of Device Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Separation Problem 2 2
Patient Device Interaction Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device-Device Incompatibility 2 2
Occlusion Within Device 2 2
Detachment Of Device Component 2 2
Disconnection 1 1
Valve(s) 1 1
Inability to Irrigate 1 1
Kinked 1 1
Material Rupture 1 1
Failure to Read Input Signal 1 1
Improper or Incorrect Procedure or Method 1 1
Ambient Noise Problem 1 1
Device Sensing Problem 1 1
Positioning Problem 1 1
Obstruction of Flow 1 1
Device Handling Problem 1 1
Component Missing 1 1
Stretched 1 1
Failure to Unfold or Unwrap 1 1
Defective Device 1 1
Folded 1 1
Communication or Transmission Problem 1 1
No Flow 1 1
Physical Property Issue 1 1
Device Packaging Compromised 1 1
Device Dislodged or Dislocated 1 1
Gas Leak 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Puncture/Hole 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Failure to Sense 1 1
Complete Blockage 1 1
Tube 1 1
Ring 1 1
Air Leak 1 1
Display or Visual Feedback Problem 1 1
False Reading From Device Non-Compliance 1 1
Fluid 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
Foreign Body In Patient 10 10
No Clinical Signs, Symptoms or Conditions 7 7
Pericardial Effusion 6 6
Device Embedded In Tissue or Plaque 6 6
Cardiac Arrest 6 6
Stroke/CVA 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
Hematoma 3 3
Vascular Dissection 3 3
Complete Heart Block 2 2
Rupture 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
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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