TPLC - Total Product Life Cycle

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Device	catheter, cannula and tubing, vascular, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass vascular catheter, cannula, or tubing.
Product Code	DWF
Regulation Number	870.4210
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
EDWARDS LIFESCIENCES
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES LLC
	SUBSTANTIALLY EQUIVALENT	2
KAPP SURGICAL INSTRUMENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIVANOVA USA INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
QURA S.R.L.
	SUBSTANTIALLY EQUIVALENT	4
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	3
SPECTRUM MEDICAL S.R.L.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	444	444
Mechanical Problem	342	342
Material Deformation	304	304
Fluid/Blood Leak	233	233
Crack	221	221
Material Puncture/Hole	180	180
Contamination	155	155
Adverse Event Without Identified Device or Use Problem	143	143
Obstruction of Flow	123	124
Break	71	71
Air/Gas in Device	50	50
Misassembled During Installation	46	46
Packaging Problem	44	44
Detachment of Device or Device Component	42	42
Fracture	39	39
Device Markings/Labelling Problem	38	38
Disconnection	33	33
Leak/Splash	33	33
Difficult to Open or Close	31	31
Insufficient Information	24	24
Material Twisted/Bent	18	18
Loss of or Failure to Bond	17	17
Material Split, Cut or Torn	14	14
Material Integrity Problem	14	14
Component Missing	13	13
Material Rupture	13	13
Manufacturing, Packaging or Shipping Problem	13	13
Nonstandard Device	11	11
Difficult to Insert	10	10
Migration	9	9
Increase in Pressure	8	8
Gas/Air Leak	8	8
Improper Flow or Infusion	8	8
Use of Device Problem	7	7
Deformation Due to Compressive Stress	7	7
Partial Blockage	7	7
Ejection Problem	6	6
Particulates	6	6
Infusion or Flow Problem	6	6
Physical Resistance/Sticking	6	6
No Flow	6	6
Defective Device	5	5
Inflation Problem	5	5
Device Handling Problem	5	5
Tear, Rip or Hole in Device Packaging	5	5
Coagulation in Device or Device Ingredient	5	6
Loose or Intermittent Connection	5	5
Appropriate Term/Code Not Available	4	4
Material Discolored	4	4
Burst Container or Vessel	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1775	1775
Hemorrhage/Bleeding	184	184
Insufficient Information	65	66
No Known Impact Or Consequence To Patient	41	41
No Consequences Or Impact To Patient	27	27
Cardiac Arrest	27	27
Perforation of Vessels	26	26
Thrombosis/Thrombus	20	20
Air Embolism	18	18
Foreign Body In Patient	18	18
Low Blood Pressure/ Hypotension	18	18
Stroke/CVA	18	18
Hematoma	18	18
Exsanguination	17	17
Blood Loss	16	16
Death	15	15
Renal Failure	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Ischemia	11	11
Sepsis	11	11
Cardiac Perforation	10	10
Vascular Dissection	9	9
Device Embedded In Tissue or Plaque	9	9
Perforation	8	8
Obstruction/Occlusion	8	8
Swelling/ Edema	8	8
Cardiac Tamponade	8	8
Unspecified Infection	8	8
Hemolysis	7	7
Atrial Fibrillation	6	6
Unspecified Tissue Injury	6	6
Ischemia Stroke	5	5
Pulmonary Embolism	5	5
Bradycardia	5	5
Respiratory Failure	5	5
Hypovolemia	5	5
Pericardial Effusion	5	5
No Patient Involvement	5	5
Tricuspid Valve Insufficiency/ Regurgitation	4	4
Decreased Respiratory Rate	4	4
Brain Injury	4	4
Rupture	4	4
Bacterial Infection	4	4
Bronchopneumonia	4	4
Cardiogenic Shock	4	4
Hypoxia	4	4
Pleural Effusion	4	4
Convulsion/Seizure	4	4
Hypovolemic Shock	4	4
Pulmonary Edema	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardiac Assist, Inc	III	Nov-29-2021
2	Cardiac Assist, Inc	II	Feb-07-2020
3	Edwards Lifesciences, LLC	II	Jan-10-2020
4	LivaNova USA Inc.	II	Jun-26-2020
5	Medtronic Perfusion Systems	I	Sep-03-2025
6	Medtronic Perfusion Systems	I	Mar-13-2025
7	Medtronic Perfusion Systems	II	Jan-17-2025
8	Medtronic Perfusion Systems	II	Nov-04-2024
9	Medtronic Perfusion Systems	II	Sep-12-2024
10	Medtronic Perfusion Systems	II	May-10-2024
11	Medtronic Perfusion Systems	II	Mar-19-2024
12	Medtronic Perfusion Systems	II	Jan-12-2022
13	Medtronic Perfusion Systems	II	Oct-01-2021
14	Medtronic Perfusion Systems	II	Jun-16-2021