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	5
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
Obstruction of Flow	339	340
Patient Device Interaction Problem	311	311
Entrapment of Device	90	90
Device Contamination with Body Fluid	87	87
Detachment of Device or Device Component	75	75
Contamination /Decontamination Problem	73	73
Signal Artifact/Noise	70	70
Adverse Event Without Identified Device or Use Problem	70	70
Material Twisted/Bent	66	66
Device-Device Incompatibility	50	50
Coagulation in Device or Device Ingredient	47	47
Material Protrusion/Extrusion	42	42
Break	29	29
Material Separation	29	29
Display or Visual Feedback Problem	27	27
Communication or Transmission Problem	22	22
Material Deformation	19	19
Sharp Edges	18	18
Complete Blockage	18	18
Tear, Rip or Hole in Device Packaging	17	17
Mechanical Jam	16	16
Positioning Problem	15	15
Manufacturing, Packaging or Shipping Problem	14	14
Improper or Incorrect Procedure or Method	14	14
Packaging Problem	11	11
Failure to Sense	7	7
Off-Label Use	7	7
Failure to Advance	7	7
Delivered as Unsterile Product	6	6
Appropriate Term/Code Not Available	5	5
Application Program Problem	5	5
Electrical Shorting	5	5
Device Sensing Problem	5	5
Output Problem	4	4
Separation Problem	4	4
Insufficient Information	3	3
Material Integrity Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Contamination	3	3
Use of Device Problem	3	3
Device Displays Incorrect Message	3	3
Partial Blockage	3	3
Defective Device	2	2
Material Too Rigid or Stiff	2	2
Device Alarm System	2	2
Flushing Problem	1	1
Protective Measures Problem	1	1
Fracture	1	1
Computer Software Problem	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	834	835
Cardiac Tamponade	146	146
Foreign Body In Patient	69	69
No Consequences Or Impact To Patient	35	35
Cardiac Arrest	30	30
Cardiac Perforation	25	25
Stroke/CVA	19	19
Thrombosis/Thrombus	18	18
Ischemic Heart Disease	17	17
Air Embolism	15	15
Low Blood Pressure/ Hypotension	12	12
No Code Available	12	12
Heart Block	11	11
Insufficient Information	9	9
Pericardial Effusion	9	9
Unspecified Tissue Injury	8	8
Ventricular Fibrillation	7	7
Transient Ischemic Attack	7	7
Rupture	6	6
Arrhythmia	5	5
Myocardial Infarction	5	5
Perforation of Vessels	5	5
Tachycardia	5	5
Respiratory Failure	4	4
No Known Impact Or Consequence To Patient	4	4
Pericarditis	4	4
Hemorrhage/Bleeding	4	4
Paralysis	4	4
Heart Failure/Congestive Heart Failure	4	4
Anemia	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Hematoma	3	3
Pseudoaneurysm	3	3
Death	3	3
Nerve Damage	3	3
Urinary Tract Infection	2	2
Syncope/Fainting	2	2
Blurred Vision	2	2
Pulmonary Edema	2	2
Asystole	2	2
Bradycardia	2	2
Renal Impairment	2	2
Pneumothorax	2	2
Cardiogenic Shock	2	2
Thrombosis	2	2
Electric Shock	2	2
Ventricular Tachycardia	2	2
Hematuria	2	2
Vasoconstriction	2	2
Multiple Organ Failure	2	2