TPLC - Total Product Life Cycle

• Device: catheter, intracardiac mapping, high-density array
• Product Code: MTD
• Regulation Number: 870.1220
• Device Class: 2

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

MDR Year	MDR Reports	MDR Events
2019	77	77
2020	87	87
2021	99	99
2022	145	145
2023	184	184
2024	103	103

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient Device Interaction Problem	196	196
Adverse Event Without Identified Device or Use Problem	82	82
Entrapment of Device	79	79
Device Contamination with Body Fluid	65	65
Detachment of Device or Device Component	56	56
Contamination /Decontamination Problem	54	54
Obstruction of Flow	48	48
Signal Artifact/Noise	43	43
Coagulation in Device or Device Ingredient	40	40
Material Twisted/Bent	38	38
Material Protrusion/Extrusion	35	35
Device-Device Incompatibility	33	33
Sharp Edges	27	27
Break	25	25
Material Separation	18	18
Complete Blockage	17	17
Material Deformation	16	16
Display or Visual Feedback Problem	15	15
Mechanical Jam	11	11
Tear, Rip or Hole in Device Packaging	11	11
Positioning Problem	8	8
Manufacturing, Packaging or Shipping Problem	6	6
Packaging Problem	6	6
Communication or Transmission Problem	5	5
Delivered as Unsterile Product	5	5
Appropriate Term/Code Not Available	4	4
Failure to Advance	4	4
Separation Problem	4	4
Off-Label Use	4	4
Application Program Problem	3	3
Partial Blockage	3	3
Material Split, Cut or Torn	3	3
Therapeutic or Diagnostic Output Failure	3	3
Improper or Incorrect Procedure or Method	2	2
Device Sensing Problem	2	2
Contamination	2	2
Fracture	2	2
Electrical Shorting	2	2
Device Contamination with Chemical or Other Material	2	2
Material Fragmentation	2	2
Material Too Rigid or Stiff	2	2
Protective Measures Problem	1	1
Physical Resistance/Sticking	1	1
Fluid/Blood Leak	1	1
Output Problem	1	1
Failure to Unfold or Unwrap	1	1
Device Alarm System	1	1
Gas/Air Leak	1	1
Failure to Sense	1	1
Difficult to Remove	1	1
Material Integrity Problem	1	1
No Display/Image	1	1
Use of Device Problem	1	1
Component Missing	1	1
Electromagnetic Compatibility Problem	1	1
Material Frayed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	340	340
Cardiac Tamponade	104	104
No Consequences Or Impact To Patient	71	71
Foreign Body In Patient	50	50
No Code Available	29	29
Cardiac Perforation	22	22
Cardiac Arrest	20	20
Air Embolism	12	12
Stroke/CVA	12	12
Ischemic Heart Disease	10	10
Thrombosis/Thrombus	8	8
Rupture	7	7
Transient Ischemic Attack	6	6
Pericardial Effusion	6	6
Insufficient Information	5	5
Ventricular Fibrillation	5	5
Device Embedded In Tissue or Plaque	5	5
Low Blood Pressure/ Hypotension	4	4
Hematoma	4	4
No Known Impact Or Consequence To Patient	4	4
Unspecified Tissue Injury	4	4
Heart Block	4	4
Arrhythmia	3	3
Death	3	3
Tachycardia	3	3
Pseudoaneurysm	3	3
Paralysis	3	3
Cardiogenic Shock	2	2
Vasoconstriction	2	2
Urinary Tract Infection	2	2
Hemorrhage/Bleeding	2	2
Myocardial Infarction	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Perforation of Vessels	2	2
Bradycardia	2	2
Complete Heart Block	2	2
Thrombosis	2	2
Ventricular Tachycardia	2	2
Mitral Regurgitation	1	1
Pulmonary Embolism	1	1
Visual Impairment	1	1
Vascular Dissection	1	1
Anemia	1	1
Heart Failure/Congestive Heart Failure	1	1
Pleural Effusion	1	1
Mitral Insufficiency	1	1
Thromboembolism	1	1
Aortic Insufficiency	1	1
Pericarditis	1	1
Nerve Damage	1	1
Pneumothorax	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott	II	Jun-01-2022
2	BIOSENSE WEBSTER	II	Jun-16-2020