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 Code	MTD
Regulation Number	870.1220
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
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
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
STERILMED INC. (JOHNSON AND JOHNSON)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient Device Interaction Problem	262	262
Obstruction of Flow	187	187
Entrapment of Device	80	80
Device Contamination with Body Fluid	80	80
Detachment of Device or Device Component	69	69
Contamination /Decontamination Problem	64	64
Signal Artifact/Noise	63	63
Adverse Event Without Identified Device or Use Problem	61	61
Material Twisted/Bent	55	55
Device-Device Incompatibility	45	45
Material Protrusion/Extrusion	39	39
Coagulation in Device or Device Ingredient	39	39
Break	29	29
Display or Visual Feedback Problem	25	25
Material Separation	19	19
Complete Blockage	18	18
Sharp Edges	18	18
Material Deformation	16	16
Tear, Rip or Hole in Device Packaging	15	15
Mechanical Jam	15	15
Communication or Transmission Problem	14	14
Manufacturing, Packaging or Shipping Problem	13	13
Positioning Problem	12	12
Improper or Incorrect Procedure or Method	9	9
Packaging Problem	8	8
Off-Label Use	7	7
Delivered as Unsterile Product	6	6
Failure to Sense	5	5
Appropriate Term/Code Not Available	5	5
Application Program Problem	5	5
Electrical Shorting	4	4
Separation Problem	4	4
Failure to Advance	4	4
Contamination	3	3
Therapeutic or Diagnostic Output Failure	3	3
Partial Blockage	3	3
Material Too Rigid or Stiff	2	2
Material Integrity Problem	2	2
Insufficient Information	2	2
Device Sensing Problem	2	2
Fluid/Blood Leak	1	1
Protective Measures Problem	1	1
Failure to Unfold or Unwrap	1	1
Device Emits Odor	1	1
Electromagnetic Compatibility Problem	1	1
Component Missing	1	1
Use of Device Problem	1	1
Device Alarm System	1	1
Physical Resistance/Sticking	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	606	606
Cardiac Tamponade	124	124
Foreign Body In Patient	61	61
No Consequences Or Impact To Patient	35	35
Cardiac Arrest	24	24
Cardiac Perforation	17	17
Stroke/CVA	16	16
Ischemic Heart Disease	15	15
Air Embolism	14	14
No Code Available	12	12
Thrombosis/Thrombus	11	11
Low Blood Pressure/ Hypotension	9	9
Pericardial Effusion	9	9
Heart Block	8	8
Unspecified Tissue Injury	6	6
Insufficient Information	6	6
Ventricular Fibrillation	6	6
Transient Ischemic Attack	5	5
Rupture	5	5
No Known Impact Or Consequence To Patient	4	4
Tachycardia	4	4
Perforation of Vessels	4	4
Hematoma	3	3
Pseudoaneurysm	3	3
Death	3	3
Arrhythmia	3	3
Pericarditis	2	2
Paralysis	2	2
Vasoconstriction	2	2
Ventricular Tachycardia	2	2
Thrombosis	2	2
Cardiogenic Shock	2	2
Bradycardia	2	2
Pneumothorax	2	2
Myocardial Infarction	2	2
Hemorrhage/Bleeding	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Respiratory Failure	2	2
Urinary Tract Infection	2	2
Cognitive Changes	1	1
Anemia	1	1
Unspecified Nervous System Problem	1	1
Perforation	1	1
Respiratory Arrest	1	1
Nerve Damage	1	1
Pleural Effusion	1	1
Mitral Valve Insufficiency/ Regurgitation	1	1
Visual Impairment	1	1
Asystole	1	1
Heart Failure/Congestive Heart Failure	1	1