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	3
CARDIOGARD MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	2
KAPP SURGICAL INSTRUMENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIVANOVA USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	7
QURA S.R.L
	SUBSTANTIALLY EQUIVALENT	4
SMART REACTORS
	SUBSTANTIALLY EQUIVALENT	1
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	4
SPECTRUM MEDICAL S.R.L.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	540	540
Mechanical Problem	385	385
Material Deformation	367	370
Fluid/Blood Leak	271	275
Crack	243	252
Delivered as Unsterile Product	229	229
Material Puncture/Hole	197	198
Adverse Event Without Identified Device or Use Problem	183	183
Contamination	178	178
Obstruction of Flow	144	146
Break	94	94
Misassembled During Installation	74	74
Detachment of Device or Device Component	65	66
Air/Gas in Device	59	59
Packaging Problem	57	57
Device Markings/Labelling Problem	56	56
Disconnection	46	46
Fracture	43	43
Leak/Splash	42	42
Difficult to Open or Close	37	37
Insufficient Information	32	32
Component Missing	28	28
Material Twisted/Bent	28	28
Material Split, Cut or Torn	21	21
Manufacturing, Packaging or Shipping Problem	21	21
Loss of or Failure to Bond	18	18
Material Integrity Problem	18	18
Nonstandard Device	17	17
Material Rupture	15	15
Migration	13	13
Gas/Air Leak	13	13
Difficult to Insert	11	11
Increase in Pressure	10	10
Deformation Due to Compressive Stress	10	10
Defective Component	10	10
Improper Flow or Infusion	9	9
Use of Device Problem	8	8
Positioning Problem	8	8
Contamination /Decontamination Problem	7	7
Defective Device	7	7
No Flow	7	7
Restricted Flow rate	7	7
Physical Resistance/Sticking	7	7
Partial Blockage	7	7
Tear, Rip or Hole in Device Packaging	7	7
Device Contamination with Chemical or Other Material	7	7
Appropriate Term/Code Not Available	7	7
Unsealed Device Packaging	6	6
Particulates	6	6
Infusion or Flow Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2235	2246
Hemorrhage/Bleeding	210	213
No Known Impact Or Consequence To Patient	111	111
Insufficient Information	76	77
No Consequences Or Impact To Patient	57	57
Blood Loss	36	37
Perforation of Vessels	33	33
Cardiac Arrest	32	32
Stroke/CVA	29	29
Death	28	28
Foreign Body In Patient	23	23
Air Embolism	22	22
Low Blood Pressure/ Hypotension	22	22
Thrombosis/Thrombus	20	20
Exsanguination	19	19
Hematoma	18	18
Ischemia	17	17
Perforation	16	16
Vascular Dissection	15	15
Renal Failure	15	15
Cardiac Perforation	14	14
Cardiac Tamponade	13	13
Unspecified Infection	13	13
Sepsis	13	13
No Patient Involvement	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Device Embedded In Tissue or Plaque	11	11
Atrial Fibrillation	10	10
Swelling/ Edema	9	9
Hemolysis	8	8
Obstruction/Occlusion	8	8
Unspecified Tissue Injury	7	7
Hypoxia	7	7
Respiratory Failure	7	7
Bradycardia	6	6
Arrhythmia	6	6
Pericardial Effusion	6	6
Pulmonary Embolism	6	6
Hypovolemia	6	6
Myocardial Infarction	5	5
Laceration(s)	5	5
Rupture	5	5
Ischemia Stroke	5	5
Pulmonary Edema	4	4
Pneumonia	4	4
Convulsion/Seizure	4	4
Bacterial Infection	4	4
Cardiogenic Shock	4	4
Decreased Respiratory Rate	4	4
Pleural Effusion	4	4

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	Edwards Lifesciences, LLC	II	Nov-18-2019
5	LivaNova USA	II	Jan-23-2019
6	LivaNova USA Inc.	II	Jun-26-2020
7	Maquet Cardiovascular, LLC	II	May-31-2019
8	Medtronic Perfusion Systems	I	Sep-03-2025
9	Medtronic Perfusion Systems	I	Mar-13-2025
10	Medtronic Perfusion Systems	II	Jan-17-2025
11	Medtronic Perfusion Systems	II	Nov-04-2024
12	Medtronic Perfusion Systems	II	Sep-12-2024
13	Medtronic Perfusion Systems	II	May-10-2024
14	Medtronic Perfusion Systems	II	Mar-19-2024
15	Medtronic Perfusion Systems	II	Jan-12-2022
16	Medtronic Perfusion Systems	II	Oct-01-2021
17	Medtronic Perfusion Systems	II	Jun-16-2021
18	OriGen Biomedical, Inc.	I	Jun-04-2019