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	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	2
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	245	245
Mechanical Problem	230	230
Fluid/Blood Leak	167	167
Crack	165	165
Material Puncture/Hole	158	158
Adverse Event Without Identified Device or Use Problem	115	115
Material Separation	98	98
Obstruction of Flow	77	77
Break	55	55
Fracture	38	38
Detachment of Device or Device Component	35	35
Air/Gas in Device	31	31
Leak/Splash	31	31
Disconnection	29	29
Packaging Problem	27	27
Insufficient Information	21	21
Misassembled During Installation	19	19
Loss of or Failure to Bond	17	17
Material Twisted/Bent	17	17
Difficult to Open or Close	14	14
Material Split, Cut or Torn	14	14
Material Integrity Problem	13	13
Device Markings/Labelling Problem	11	11
Contamination	11	11
Nonstandard Device	11	11
Difficult to Insert	10	10
Component Missing	10	10
Migration	9	9
Material Rupture	9	9
Gas/Air Leak	8	8
Improper Flow or Infusion	8	8
Increase in Pressure	8	8
Infusion or Flow Problem	6	6
Ejection Problem	6	6
No Flow	6	6
Physical Resistance/Sticking	5	5
Coagulation in Device or Device Ingredient	5	5
Device Handling Problem	5	5
Deformation Due to Compressive Stress	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Defective Device	5	5
Loose or Intermittent Connection	5	5
Material Discolored	4	4
Appropriate Term/Code Not Available	4	4
Inflation Problem	4	4
Malposition of Device	4	4
Partial Blockage	4	4
Material Too Soft/Flexible	3	3
Positioning Failure	3	3
Free or Unrestricted Flow	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1029	1029
Hemorrhage/Bleeding	136	136
No Known Impact Or Consequence To Patient	41	41
Insufficient Information	41	41
No Consequences Or Impact To Patient	27	27
Perforation of Vessels	22	22
Cardiac Arrest	22	22
Thrombosis/Thrombus	19	19
Blood Loss	16	16
Hematoma	16	16
Exsanguination	16	16
Low Blood Pressure/ Hypotension	15	15
Death	15	15
Foreign Body In Patient	14	14
Air Embolism	14	14
Sepsis	11	11
Ischemia	10	10
Cardiac Perforation	9	9
Vascular Dissection	9	9
Stroke/CVA	9	9
Device Embedded In Tissue or Plaque	8	8
Swelling/ Edema	8	8
Obstruction/Occlusion	8	8
Perforation	7	7
Unspecified Infection	7	7
Cardiac Tamponade	6	6
Renal Failure	5	5
Hypovolemia	5	5
No Patient Involvement	5	5
Bradycardia	5	5
Respiratory Failure	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Hemolysis	5	5
Unspecified Tissue Injury	5	5
Convulsion/Seizure	5	5
Pulmonary Embolism	4	4
Bacterial Infection	4	4
Brain Injury	4	4
Tricuspid Valve Insufficiency/ Regurgitation	4	4
Decreased Respiratory Rate	4	4
Rupture	4	4
Bronchopneumonia	4	4
Hypoxia	4	4
Pulmonary Hypertension	3	3
Ventricular Fibrillation	3	3
Sinus Perforation	3	3
Pulmonary Edema	3	3
Multiple Organ Failure	3	3
Pneumothorax	2	2
Pleural Effusion	2	2

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	II	Jan-17-2025
6	Medtronic Perfusion Systems	II	Nov-04-2024
7	Medtronic Perfusion Systems	II	Sep-12-2024
8	Medtronic Perfusion Systems	II	May-10-2024
9	Medtronic Perfusion Systems	II	Mar-19-2024
10	Medtronic Perfusion Systems	II	Jan-12-2022
11	Medtronic Perfusion Systems	II	Oct-01-2021
12	Medtronic Perfusion Systems	II	Jun-16-2021