TPLC - Total Product Life Cycle

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

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Deformation	238	238
Mechanical Problem	192	192
Fluid/Blood Leak	171	171
Crack	163	163
Material Puncture/Hole	161	161
Adverse Event Without Identified Device or Use Problem	139	139
Material Separation	108	108
Obstruction of Flow	74	74
Break	62	62
Detachment of Device or Device Component	48	48
Disconnection	42	42
Leak/Splash	40	40
Fracture	40	40
Air/Gas in Device	28	28
Packaging Problem	27	27
Insufficient Information	27	27
Material Twisted/Bent	25	25
Misassembled During Installation	19	19
Material Split, Cut or Torn	19	19
Loss of or Failure to Bond	18	18
Nonstandard Device	17	17
Device Markings/Labelling Problem	14	14
Gas/Air Leak	13	13
Migration	13	13
Material Integrity Problem	13	13
Difficult to Open or Close	13	13
Contamination	11	11
Difficult to Insert	11	11
Material Rupture	10	10
Component Missing	10	10
Defective Component	9	9
Improper Flow or Infusion	9	9
Defective Device	7	7
Device Contamination with Chemical or Other Material	7	7
Deformation Due to Compressive Stress	7	7
Increase in Pressure	7	7
Physical Resistance/Sticking	6	6
Coagulation in Device or Device Ingredient	6	6
Unsealed Device Packaging	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Infusion or Flow Problem	6	6
Appropriate Term/Code Not Available	6	6
Loose or Intermittent Connection	6	6
Ejection Problem	6	6
No Flow	6	6
Restricted Flow rate	5	5
Positioning Problem	5	5
Malposition of Device	5	5
Improper or Incorrect Procedure or Method	5	5
Device Handling Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	963	963
Hemorrhage/Bleeding	136	136
No Known Impact Or Consequence To Patient	111	111
No Consequences Or Impact To Patient	57	57
Insufficient Information	40	40
Blood Loss	36	36
Death	27	27
Cardiac Arrest	25	25
Perforation of Vessels	23	23
Thrombosis/Thrombus	18	18
Exsanguination	18	18
Low Blood Pressure/ Hypotension	17	17
Air Embolism	16	16
Hematoma	16	16
Cardiac Perforation	13	13
Ischemia	13	13
No Patient Involvement	11	11
Foreign Body In Patient	11	11
Cardiac Tamponade	11	11
Perforation	11	11
Sepsis	11	11
Vascular Dissection	10	10
Device Embedded In Tissue or Plaque	10	10
Stroke/CVA	10	10
Swelling/ Edema	8	8
Obstruction/Occlusion	8	8
Unspecified Infection	7	7
Respiratory Failure	6	6
Bradycardia	6	6
Hemolysis	6	6
Hypovolemia	6	6
Pulmonary Embolism	5	5
Hypoxia	5	5
Convulsion/Seizure	5	5
Unspecified Tissue Injury	5	5
Renal Failure	5	5
Rupture	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Laceration(s)	4	4
Bacterial Infection	4	4
Bronchopneumonia	4	4
Decreased Respiratory Rate	4	4
Tricuspid Valve Insufficiency/ Regurgitation	4	4
No Code Available	4	4
Multiple Organ Failure	4	4
Brain Injury	4	4
Pulmonary Edema	3	3
Pulmonary Hypertension	3	3
Venipuncture	3	3
Low Oxygen Saturation	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	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	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
15	OriGen Biomedical, Inc.	I	Jun-04-2019