TPLC - Total Product Life Cycle

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Device	catheter, peripheral, atherectomy
Regulation Description	Intraluminal artery stripper.
Product Code	MCW
Regulation Number	870.4875
Device Class	2

Premarket Reviews
Manufacturer	Decision
AVINGER, INC.
	SUBSTANTIALLY EQUIVALENT	2
BARD PERIPHERAL VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDIO FLOW INC.,
	SUBSTANTIALLY EQUIVALENT	4
CARDIOVASCUALR SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDIOVASCULAR SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
EXIMO MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
EXIMO MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	5
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
REX MEDICAL, L.P.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRANETICS
	SUBSTANTIALLY EQUIVALENT	1
SPECTRANETICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VOLCANO ATHEROMED, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	952	1565
Detachment of Device or Device Component	709	954
Adverse Event Without Identified Device or Use Problem	614	1468
Entrapment of Device	440	445
Mechanical Jam	339	340
Material Deformation	333	457
Material Separation	277	277
Physical Resistance/Sticking	254	255
Difficult to Remove	235	235
Mechanical Problem	106	106
Noise, Audible	103	104
Suction Problem	94	94
Retraction Problem	89	89
Difficult to Advance	86	86
Leak/Splash	81	81
Fracture	80	82
Deformation Due to Compressive Stress	67	67
Failure to Advance	66	66
Unexpected Shutdown	46	46
Stretched	46	46
Device Damaged by Another Device	44	44
Improper or Incorrect Procedure or Method	37	37
Overheating of Device	36	36
Activation Problem	29	29
Device Markings/Labelling Problem	29	31
Device-Device Incompatibility	26	26
Positioning Problem	25	25
Defective Device	25	25
Melted	22	22
Material Split, Cut or Torn	20	20
Fluid/Blood Leak	18	18
Suction Failure	18	18
Insufficient Information	17	17
Flushing Problem	17	17
Material Puncture/Hole	15	15
Unintended System Motion	15	15
Off-Label Use	15	15
Device Contaminated at the User Facility	15	15
Peeled/Delaminated	14	14
Material Integrity Problem	13	13
Intermittent Loss of Power	13	13
Device Contamination with Chemical or Other Material	12	12
Device Handling Problem	11	11
Difficult or Delayed Activation	10	10
Unintended Movement	9	9
Air/Gas in Device	9	9
Missing Information	8	9
Device Difficult to Setup or Prepare	8	8
Component or Accessory Incompatibility	8	8
Unsealed Device Packaging	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2463	3081
Embolism/Embolus	251	495
Foreign Body In Patient	227	228
Vascular Dissection	200	567
Perforation of Vessels	139	261
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	134	135
Insufficient Information	95	97
Obstruction/Occlusion	78	78
Device Embedded In Tissue or Plaque	72	72
Thrombosis/Thrombus	71	71
Unintended Radiation Exposure	70	924
Perforation	60	60
Pain	39	39
Restenosis	36	36
Stenosis	35	35
Hemorrhage/Bleeding	32	32
Ischemia	29	29
Pseudoaneurysm	28	28
Hematoma	28	28
Aneurysm	21	21
Unspecified Tissue Injury	20	20
Vasoconstriction	18	18
Myocardial Infarction	14	14
Fistula	11	11
No Consequences Or Impact To Patient	8	8
Stroke/CVA	7	7
Rupture	7	7
Extravasation	7	7
Low Blood Pressure/ Hypotension	6	6
Hypersensitivity/Allergic reaction	5	5
Sepsis	5	5
Swelling/ Edema	5	5
Thromboembolism	4	4
Intraoperative Pain	4	4
Cardiac Arrest	4	4
Foreign Body Embolism	4	4
Arteriosclerosis/ Atherosclerosis	3	3
Tachycardia	3	3
Renal Failure	3	3
Fever	3	3
Unspecified Infection	3	3
Nausea	3	3
No Known Impact Or Consequence To Patient	3	125
High Blood Pressure/ Hypertension	2	2
Unspecified Vascular Problem	2	2
Cancer	2	2
Arrhythmia	2	2
Cardiovascular Insufficiency	2	2
Radiation Exposure, Unintended	2	124
Heart Failure/Congestive Heart Failure	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Angiodynamics, Inc.	II	Dec-27-2024
2	Bard Peripheral Vascular Inc	I	Mar-05-2025
3	Cardiovascular Systems Inc	II	Aug-28-2021
4	Spectranetics Corporation	II	Dec-16-2024
5	Spectranetics Corporation	II	Dec-08-2023
6	ev3 Inc.	I	Mar-07-2022
7	ev3 Inc.	I	Jan-19-2022