TPLC - Total Product Life Cycle

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Device	catheter, intracardiac mapping, high-density array
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	220	220
Obstruction of Flow	122	122
Adverse Event Without Identified Device or Use Problem	85	85
Entrapment of Device	84	84
Device Contamination with Body Fluid	75	75
Detachment of Device or Device Component	63	63
Contamination /Decontamination Problem	58	58
Signal Artifact/Noise	55	55
Coagulation in Device or Device Ingredient	48	48
Material Twisted/Bent	44	44
Material Protrusion/Extrusion	38	38
Device-Device Incompatibility	36	36
Sharp Edges	27	27
Break	26	26
Display or Visual Feedback Problem	20	20
Material Separation	20	20
Complete Blockage	18	18
Material Deformation	16	16
Mechanical Jam	13	13
Tear, Rip or Hole in Device Packaging	12	12
Positioning Problem	12	12
Communication or Transmission Problem	11	11
Manufacturing, Packaging or Shipping Problem	10	10
Packaging Problem	7	7
Delivered as Unsterile Product	5	5
Off-Label Use	5	5
Electrical Shorting	4	4
Failure to Advance	4	4
Appropriate Term/Code Not Available	4	4
Separation Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Contamination	3	3
Therapeutic or Diagnostic Output Failure	3	3
Application Program Problem	3	3
Partial Blockage	3	3
Material Split, Cut or Torn	3	3
Material Fragmentation	2	2
Material Too Rigid or Stiff	2	2
Material Integrity Problem	2	2
Failure to Sense	2	2
Insufficient Information	2	2
Device Sensing Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Fracture	2	2
Difficult to Remove	1	1
Use of Device Problem	1	1
Component Missing	1	1
Gas/Air Leak	1	1
Device Alarm System	1	1
Electromagnetic Compatibility Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	478	478
Cardiac Tamponade	115	115
No Consequences Or Impact To Patient	71	71
Foreign Body In Patient	55	55
No Code Available	29	29
Cardiac Perforation	24	24
Cardiac Arrest	22	22
Stroke/CVA	15	15
Air Embolism	14	14
Ischemic Heart Disease	11	11
Thrombosis/Thrombus	9	9
Rupture	7	7
Low Blood Pressure/ Hypotension	6	6
Pericardial Effusion	6	6
Transient Ischemic Attack	6	6
Device Embedded In Tissue or Plaque	5	5
Heart Block	5	5
Insufficient Information	5	5
Ventricular Fibrillation	5	5
Hematoma	4	4
Unspecified Tissue Injury	4	4
Perforation of Vessels	4	4
Tachycardia	4	4
No Known Impact Or Consequence To Patient	4	4
Arrhythmia	3	3
Death	3	3
Pseudoaneurysm	3	3
Paralysis	3	3
Urinary Tract Infection	2	2
Hemorrhage/Bleeding	2	2
Myocardial Infarction	2	2
Bradycardia	2	2
Cardiogenic Shock	2	2
Thrombosis	2	2
Pericarditis	2	2
Complete Heart Block	2	2
Vasoconstriction	2	2
Ventricular Tachycardia	2	2
Pneumothorax	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Nerve Damage	1	1
Pleural Effusion	1	1
Visual Impairment	1	1
Cognitive Changes	1	1
Heart Failure/Congestive Heart Failure	1	1
Anemia	1	1
Perforation	1	1
Mitral Regurgitation	1	1
Vascular Dissection	1	1
Mitral Insufficiency	1	1