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
Mechanical Problem	279	279
Material Separation	255	255
Material Deformation	254	254
Crack	178	178
Fluid/Blood Leak	177	177
Material Puncture/Hole	161	161
Adverse Event Without Identified Device or Use Problem	128	128
Obstruction of Flow	77	77
Break	56	56
Fracture	38	38
Detachment of Device or Device Component	35	35
Air/Gas in Device	32	32
Disconnection	31	31
Leak/Splash	31	31
Misassembled During Installation	31	31
Packaging Problem	27	27
Device Markings/Labelling Problem	23	23
Insufficient Information	21	21
Material Twisted/Bent	17	17
Loss of or Failure to Bond	17	17
Difficult to Open or Close	15	15
Material Split, Cut or Torn	14	14
Material Integrity Problem	13	13
Contamination	13	13
Material Rupture	11	11
Nonstandard Device	11	11
Component Missing	11	11
Difficult to Insert	10	10
Migration	9	9
Increase in Pressure	8	8
Improper Flow or Infusion	8	8
Gas/Air Leak	8	8
Deformation Due to Compressive Stress	6	6
Infusion or Flow Problem	6	6
Ejection Problem	6	6
No Flow	6	6
Physical Resistance/Sticking	5	5
Device Handling Problem	5	5
Loose or Intermittent Connection	5	5
Coagulation in Device or Device Ingredient	5	5
Defective Device	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Partial Blockage	4	4
Appropriate Term/Code Not Available	4	4
Tear, Rip or Hole in Device Packaging	4	4
Inflation Problem	4	4
Use of Device Problem	4	4
Material Discolored	4	4
Malposition of Device	4	4
Material Too Rigid or Stiff	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1276	1276
Hemorrhage/Bleeding	145	145
Insufficient Information	51	51
No Known Impact Or Consequence To Patient	41	41
No Consequences Or Impact To Patient	27	27
Perforation of Vessels	24	24
Cardiac Arrest	22	22
Thrombosis/Thrombus	19	19
Air Embolism	16	16
Blood Loss	16	16
Hematoma	16	16
Exsanguination	16	16
Foreign Body In Patient	15	15
Stroke/CVA	15	15
Death	15	15
Low Blood Pressure/ Hypotension	15	15
Renal Failure	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Sepsis	11	11
Ischemia	10	10
Cardiac Perforation	9	9
Vascular Dissection	9	9
Swelling/ Edema	8	8
Obstruction/Occlusion	8	8
Device Embedded In Tissue or Plaque	8	8
Perforation	7	7
Unspecified Infection	7	7
Atrial Fibrillation	6	6
Cardiac Tamponade	6	6
Hemolysis	5	5
Convulsion/Seizure	5	5
Respiratory Failure	5	5
Unspecified Tissue Injury	5	5
Pulmonary Embolism	5	5
Hypovolemia	5	5
No Patient Involvement	5	5
Bradycardia	5	5
Tricuspid Valve Insufficiency/ Regurgitation	4	4
Bacterial Infection	4	4
Rupture	4	4
Brain Injury	4	4
Hypoxia	4	4
Decreased Respiratory Rate	4	4
Bronchopneumonia	4	4
Sinus Perforation	3	3
Multiple Organ Failure	3	3
Ventricular Fibrillation	3	3
Pulmonary Hypertension	3	3
Pulmonary Edema	3	3
Laceration(s)	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	LivaNova USA Inc.	II	Jun-26-2020
5	Medtronic Perfusion Systems	I	Mar-13-2025
6	Medtronic Perfusion Systems	II	Jan-17-2025
7	Medtronic Perfusion Systems	II	Nov-04-2024
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