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TPLC
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Device
catheter, intracardiac mapping, high-density array
Regulation Description
Electrode recording catheter or electrode recording probe.
Product Code
MTD
Regulation Number
870.1220
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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