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
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	711	1321
Detachment of Device or Device Component	620	864
Adverse Event Without Identified Device or Use Problem	523	1499
Entrapment of Device	455	455
Material Separation	274	274
Material Deformation	263	385
Physical Resistance/Sticking	228	228
Difficult to Remove	221	221
Mechanical Jam	204	204
Mechanical Problem	141	141
Fracture	111	111
Suction Problem	108	108
Difficult to Advance	79	79
Noise, Audible	77	77
Device Damaged by Another Device	71	71
Leak/Splash	64	64
Retraction Problem	61	61
Failure to Advance	48	48
Positioning Problem	34	34
Unexpected Shutdown	34	34
Use of Device Problem	31	31
Improper or Incorrect Procedure or Method	29	29
Device Markings/Labelling Problem	28	28
Defective Device	26	26
Deformation Due to Compressive Stress	23	23
Overheating of Device	23	23
Stretched	20	20
Fluid/Blood Leak	19	19
Material Integrity Problem	17	17
Device-Device Incompatibility	16	16
Material Split, Cut or Torn	16	16
Off-Label Use	15	15
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
Melted	13	13
Device Contamination with Chemical or Other Material	13	13
Activation Problem	12	12
Insufficient Information	11	11
No Apparent Adverse Event	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	1865	2475
No Consequences Or Impact To Patient	271	271
Foreign Body In Patient	216	216
Vascular Dissection	188	554
Embolism/Embolus	182	426
Perforation of Vessels	144	266
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	131	131
Device Embedded In Tissue or Plaque	88	88
Insufficient Information	79	79
No Known Impact Or Consequence To Patient	70	192
Perforation	70	70
Unintended Radiation Exposure	59	913
Thrombosis/Thrombus	54	54
Obstruction/Occlusion	40	40
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
Vascular System (Circulation), Impaired	17	17
Vasoconstriction	16	16
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
Stroke/CVA	5	5
Swelling/ Edema	5	5
Foreign Body Embolism	4	4
Intraoperative Pain	4	4
Hypersensitivity/Allergic reaction	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