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	1
CARDIO FLOW, INC.
	SUBSTANTIALLY EQUIVALENT	2
CARDIOVASCUALR SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
CARDIOVASCULAR SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	3
1. K203008 DIAMONDBACK 360 Peripheral Orbital Atherectomy Sys ...
2. K210586 Diamonback 360 Peripheral Orbital Atherectomy Syst ...
3. K220109 DIAMONDBACK 360 Peripheral Orbital Atherectomy Sys ...
EXIMO MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	4
EXIMO MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	2
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	728	1338
Detachment of Device or Device Component	634	878
Adverse Event Without Identified Device or Use Problem	530	1506
Entrapment of Device	459	459
Material Separation	278	278
Material Deformation	268	390
Physical Resistance/Sticking	229	229
Difficult to Remove	223	223
Mechanical Jam	210	210
Mechanical Problem	141	141
Fracture	111	111
Suction Problem	109	109
Difficult to Advance	81	81
Noise, Audible	79	79
Device Damaged by Another Device	71	71
Leak/Splash	64	64
Retraction Problem	64	64
Failure to Advance	50	50
Positioning Problem	34	34
Unexpected Shutdown	34	34
Use of Device Problem	31	31
Improper or Incorrect Procedure or Method	30	30
Device Markings/Labelling Problem	28	28
Defective Device	26	26
Deformation Due to Compressive Stress	24	24
Overheating of Device	23	23
Stretched	22	22
Fluid/Blood Leak	20	20
Material Integrity Problem	17	17
Device-Device Incompatibility	16	16
Material Split, Cut or Torn	16	16
Melted	15	15
Off-Label Use	15	15
Activation Problem	14	14
Material Puncture/Hole	14	14
Intermittent Loss of Power	14	14
Difficult or Delayed Activation	13	13
Device Difficult to Setup or Prepare	13	13
Peeled/Delaminated	13	13
Device Contamination with Chemical or Other Material	13	13
No Apparent Adverse Event	11	11
Insufficient Information	11	11
Device Handling Problem	10	10
Flushing Problem	10	10
Material Twisted/Bent	9	9
Display or Visual Feedback Problem	9	9
Device Displays Incorrect Message	9	9
Infusion or Flow Problem	8	8
Failure to Prime	8	8
Difficult to Insert	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1903	2513
No Consequences Or Impact To Patient	271	271
Foreign Body In Patient	220	220
Vascular Dissection	189	555
Embolism/Embolus	183	427
Perforation of Vessels	145	267
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	133	133
Device Embedded In Tissue or Plaque	88	88
Insufficient Information	79	79
Perforation	71	71
No Known Impact Or Consequence To Patient	70	192
Unintended Radiation Exposure	59	913
Thrombosis/Thrombus	54	54
Obstruction/Occlusion	42	42
Stenosis	38	38
Pain	35	35
Hematoma	29	29
Pseudoaneurysm	28	28
Embolism	28	150
Hemorrhage/Bleeding	24	24
Unspecified Tissue Injury	20	20
Restenosis	20	20
Aneurysm	19	19
Vessel Or Plaque, Device Embedded In	19	19
Radiation Exposure, Unintended	18	140
Vasoconstriction	17	17
Vascular System (Circulation), Impaired	17	17
Iatrogenic Source	14	14
Injury	14	14
Ischemia	13	13
Fistula	12	12
Myocardial Infarction	12	12
No Code Available	11	11
Rupture	10	10
Extravasation	8	8
Occlusion	7	7
Renal Failure	6	6
Reocclusion	6	6
Thromboembolism	6	6
Low Blood Pressure/ Hypotension	6	6
Cardiac Arrest	6	6
Intimal Dissection	6	6
Sepsis	5	5
Hypersensitivity/Allergic reaction	5	5
Stroke/CVA	5	5
Swelling/ Edema	5	5
Foreign Body Embolism	4	4
Intraoperative Pain	4	4
Fever	3	3
Nausea	3	3

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