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	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	6
1. K201100 Bio-Medicus Life Support Catheter and Introducer
2. K230960 DLP™ Silicone Coronary Artery Ostial Cannulae
3. K231206 DLP Silicone Coronary Artery Ostial Cannulae
4. K251258 MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage V ...
5. K253203 Retrograde Coronary Sinus Perfusion Cannulae
6. K253998 Clearview Intracoronary Shunts
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	512	512
Mechanical Problem	370	370
Material Deformation	349	352
Fluid/Blood Leak	251	255
Crack	232	241
Delivered as Unsterile Product	215	215
Material Puncture/Hole	187	188
Contamination	177	177
Adverse Event Without Identified Device or Use Problem	153	153
Obstruction of Flow	141	143
Break	79	79
Misassembled During Installation	73	73
Packaging Problem	54	54
Air/Gas in Device	54	54
Device Markings/Labelling Problem	53	53
Detachment of Device or Device Component	49	50
Fracture	39	39
Difficult to Open or Close	35	35
Disconnection	33	33
Leak/Splash	33	33
Component Missing	26	26
Insufficient Information	25	25
Manufacturing, Packaging or Shipping Problem	20	20
Material Twisted/Bent	20	20
Loss of or Failure to Bond	17	17
Material Integrity Problem	16	16
Material Split, Cut or Torn	15	15
Material Rupture	14	14
Nonstandard Device	11	11
Increase in Pressure	10	10
Difficult to Insert	10	10
Migration	9	9
Deformation Due to Compressive Stress	8	8
Improper Flow or Infusion	8	8
Gas/Air Leak	8	8
Use of Device Problem	8	8
No Flow	7	7
Partial Blockage	7	7
Physical Resistance/Sticking	6	6
Tear, Rip or Hole in Device Packaging	6	6
Infusion or Flow Problem	6	6
Particulates	6	6
Ejection Problem	6	6
Loose or Intermittent Connection	5	5
Coagulation in Device or Device Ingredient	5	6
Appropriate Term/Code Not Available	5	5
Defective Device	5	5
Positioning Problem	5	5
Device Handling Problem	5	5
Contamination /Decontamination Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2168	2179
Hemorrhage/Bleeding	199	202
Insufficient Information	70	71
No Known Impact Or Consequence To Patient	41	41
Perforation of Vessels	31	31
Cardiac Arrest	29	29
No Consequences Or Impact To Patient	27	27
Stroke/CVA	26	26
Foreign Body In Patient	20	20
Thrombosis/Thrombus	20	20
Low Blood Pressure/ Hypotension	19	19
Hematoma	18	18
Air Embolism	18	18
Exsanguination	17	17
Blood Loss	16	16
Death	15	15
Renal Failure	15	15
Sepsis	13	13
Vascular Dissection	13	13
Ischemia	12	12
Perforation	12	12
Unspecified Infection	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Cardiac Perforation	10	10
Atrial Fibrillation	10	10
Device Embedded In Tissue or Plaque	9	9
Swelling/ Edema	9	9
Obstruction/Occlusion	8	8
Cardiac Tamponade	8	8
Hemolysis	7	7
Unspecified Tissue Injury	7	7
Respiratory Failure	6	6
No Patient Involvement	5	5
Ischemia Stroke	5	5
Pericardial Effusion	5	5
Bradycardia	5	5
Pulmonary Embolism	5	5
Arrhythmia	5	5
Hypovolemia	5	5
Myocardial Infarction	5	5
Pleural Effusion	4	4
Pneumonia	4	4
Cardiogenic Shock	4	4
Bronchopneumonia	4	4
Rupture	4	4
Brain Injury	4	4
Bacterial Infection	4	4
Hypovolemic Shock	4	4
Hypoxia	4	4
Convulsion/Seizure	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	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