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	2
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	782	1392
Detachment of Device or Device Component	670	914
Adverse Event Without Identified Device or Use Problem	542	1518
Entrapment of Device	471	471
Material Separation	290	290
Material Deformation	278	400
Physical Resistance/Sticking	233	233
Difficult to Remove	228	228
Mechanical Jam	227	227
Mechanical Problem	143	143
Fracture	113	113
Suction Problem	110	110
Difficult to Advance	86	86
Noise, Audible	83	83
Device Damaged by Another Device	72	72
Leak/Splash	70	70
Retraction Problem	70	70
Failure to Advance	52	52
Unexpected Shutdown	39	39
Positioning Problem	35	35
Use of Device Problem	31	31
Deformation Due to Compressive Stress	31	31
Improper or Incorrect Procedure or Method	31	31
Device Markings/Labelling Problem	28	28
Defective Device	27	27
Stretched	24	24
Overheating of Device	24	24
Fluid/Blood Leak	20	20
Device-Device Incompatibility	18	18
Material Split, Cut or Torn	17	17
Material Integrity Problem	17	17
Off-Label Use	16	16
Melted	15	15
Activation Problem	15	15
Intermittent Loss of Power	15	15
Peeled/Delaminated	14	14
Material Puncture/Hole	14	14
Difficult or Delayed Activation	13	13
Device Difficult to Setup or Prepare	13	13
Device Contamination with Chemical or Other Material	13	13
Insufficient Information	11	11
No Apparent Adverse Event	11	11
Unintended System Motion	10	10
Flushing Problem	10	10
Device Handling Problem	10	10
Output Problem	9	9
Material Twisted/Bent	9	9
Display or Visual Feedback Problem	9	9
Device Displays Incorrect Message	9	9
Infusion or Flow Problem	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1992	2602
No Consequences Or Impact To Patient	271	271
Foreign Body In Patient	223	223
Vascular Dissection	192	558
Embolism/Embolus	192	436
Perforation of Vessels	147	269
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	136	136
Device Embedded In Tissue or Plaque	90	90
Insufficient Information	82	82
Perforation	71	71
No Known Impact Or Consequence To Patient	70	192
Unintended Radiation Exposure	59	913
Thrombosis/Thrombus	57	57
Obstruction/Occlusion	48	48
Stenosis	38	38
Pain	36	36
Hematoma	29	29
Embolism	28	150
Pseudoaneurysm	28	28
Hemorrhage/Bleeding	24	24
Restenosis	21	21
Unspecified Tissue Injury	20	20
Vessel Or Plaque, Device Embedded In	19	19
Aneurysm	19	19
Radiation Exposure, Unintended	18	140
Vascular System (Circulation), Impaired	17	17
Vasoconstriction	17	17
Injury	14	14
Iatrogenic Source	14	14
Ischemia	13	13
Myocardial Infarction	12	12
Fistula	12	12
No Code Available	11	11
Rupture	10	10
Extravasation	8	8
Occlusion	7	7
Cardiac Arrest	6	6
Thromboembolism	6	6
Low Blood Pressure/ Hypotension	6	6
Intimal Dissection	6	6
Renal Failure	6	6
Reocclusion	6	6
Swelling/ Edema	5	5
Sepsis	5	5
Hypersensitivity/Allergic reaction	5	5
Stroke/CVA	5	5
Intraoperative Pain	4	4
Foreign Body Embolism	4	4
Blood Loss	3	3
Fever	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