TPLC - Total Product Life Cycle

show TPLC since

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	206	206
Mechanical Problem	178	178
Fluid/Blood Leak	160	160
Material Puncture/Hole	156	156
Crack	150	150
Adverse Event Without Identified Device or Use Problem	137	137
Material Separation	105	105
Obstruction of Flow	64	64
Break	60	60
Detachment of Device or Device Component	47	47
Disconnection	42	42
Leak/Splash	40	40
Fracture	39	39
Insufficient Information	26	26
Packaging Problem	25	25
Air/Gas in Device	25	25
Material Twisted/Bent	25	25
Material Split, Cut or Torn	19	19
Loss of or Failure to Bond	18	18
Nonstandard Device	17	17
Misassembled During Installation	14	14
Migration	13	13
Gas/Air Leak	13	13
Contamination	11	11
Difficult to Insert	11	11
Device Markings/Labelling Problem	10	10
Component Missing	10	10
Material Rupture	9	9
Material Integrity Problem	9	9
Defective Component	9	9
Improper Flow or Infusion	9	9
Deformation Due to Compressive Stress	7	7
Device Contamination with Chemical or Other Material	7	7
Defective Device	7	7
Increase in Pressure	7	7
Physical Resistance/Sticking	6	6
No Flow	6	6
Loose or Intermittent Connection	6	6
Infusion or Flow Problem	6	6
Ejection Problem	6	6
Coagulation in Device or Device Ingredient	6	6
Improper or Incorrect Procedure or Method	5	5
Restricted Flow rate	5	5
Positioning Problem	5	5
Appropriate Term/Code Not Available	5	5
Unsealed Device Packaging	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Positioning Failure	5	5
Material Discolored	5	5
Device Handling Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	859	859
Hemorrhage/Bleeding	135	135
No Known Impact Or Consequence To Patient	111	111
No Consequences Or Impact To Patient	57	57
Insufficient Information	36	36
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	16	16
Hematoma	16	16
Air Embolism	14	14
Ischemia	13	13
Cardiac Perforation	12	12
Sepsis	11	11
No Patient Involvement	11	11
Perforation	11	11
Cardiac Tamponade	11	11
Stroke/CVA	10	10
Device Embedded In Tissue or Plaque	10	10
Vascular Dissection	9	9
Swelling/ Edema	8	8
Foreign Body In Patient	8	8
Obstruction/Occlusion	8	8
Unspecified Infection	7	7
Hypovolemia	6	6
Hemolysis	6	6
Respiratory Failure	6	6
Bradycardia	6	6
Pulmonary Embolism	5	5
Renal Failure	5	5
Rupture	5	5
Hypoxia	5	5
Convulsion/Seizure	5	5
Bacterial Infection	4	4
Laceration(s)	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Multiple Organ Failure	4	4
Tricuspid Valve Insufficiency/ Regurgitation	4	4
Decreased Respiratory Rate	4	4
Bronchopneumonia	4	4
No Code Available	4	4
Brain Injury	4	4
Unspecified Tissue Injury	3	3
Low Oxygen Saturation	3	3
Pulmonary Hypertension	3	3
Pulmonary Edema	3	3
Venipuncture	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	Sep-12-2024
9	Medtronic Perfusion Systems	II	May-10-2024
10	Medtronic Perfusion Systems	II	Mar-19-2024
11	Medtronic Perfusion Systems	II	Jan-12-2022
12	Medtronic Perfusion Systems	II	Oct-01-2021
13	Medtronic Perfusion Systems	II	Jun-16-2021
14	OriGen Biomedical, Inc.	I	Jun-04-2019