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	854	1465
Detachment of Device or Device Component	731	975
Adverse Event Without Identified Device or Use Problem	584	1560
Entrapment of Device	503	503
Material Deformation	316	438
Material Separation	313	313
Mechanical Jam	288	289
Difficult to Remove	253	253
Physical Resistance/Sticking	250	251
Mechanical Problem	144	144
Suction Problem	121	121
Fracture	114	115
Difficult to Advance	90	90
Leak/Splash	87	87
Noise, Audible	86	86
Retraction Problem	83	83
Device Damaged by Another Device	79	79
Failure to Advance	62	62
Deformation Due to Compressive Stress	48	48
Unexpected Shutdown	45	45
Positioning Problem	35	35
Improper or Incorrect Procedure or Method	35	35
Use of Device Problem	33	33
Stretched	31	31
Defective Device	30	30
Overheating of Device	30	30
Device Markings/Labelling Problem	28	29
Device-Device Incompatibility	23	23
Fluid/Blood Leak	22	22
Material Split, Cut or Torn	22	22
Activation Problem	18	18
Material Integrity Problem	17	17
Intermittent Loss of Power	17	17
Off-Label Use	17	17
Melted	17	17
Unintended System Motion	15	15
Insufficient Information	14	14
Material Puncture/Hole	14	14
Flushing Problem	14	14
Peeled/Delaminated	14	14
Device Contamination with Chemical or Other Material	13	13
Device Difficult to Setup or Prepare	13	13
Device Contaminated at the User Facility	13	13
Difficult or Delayed Activation	13	13
Device Handling Problem	12	12
No Apparent Adverse Event	11	11
Display or Visual Feedback Problem	10	10
Output Problem	10	10
Air/Gas in Device	9	9
Device Displays Incorrect Message	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2228	2838
No Consequences Or Impact To Patient	271	271
Foreign Body In Patient	242	243
Embolism/Embolus	216	460
Vascular Dissection	195	561
Perforation of Vessels	168	290
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	139	139
Device Embedded In Tissue or Plaque	94	94
Insufficient Information	84	86
Perforation	72	72
No Known Impact Or Consequence To Patient	70	192
Obstruction/Occlusion	65	65
Thrombosis/Thrombus	64	64
Unintended Radiation Exposure	63	917
Pain	41	41
Stenosis	39	39
Hemorrhage/Bleeding	30	30
Hematoma	30	30
Pseudoaneurysm	29	29
Embolism	28	150
Restenosis	21	21
Unspecified Tissue Injury	20	20
Aneurysm	20	20
Vessel Or Plaque, Device Embedded In	19	19
Vasoconstriction	18	18
Radiation Exposure, Unintended	18	140
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
Low Blood Pressure/ Hypotension	7	7
Occlusion	7	7
Renal Failure	7	7
Thromboembolism	6	6
Intimal Dissection	6	6
Cardiac Arrest	6	6
Reocclusion	6	6
Sepsis	5	5
Swelling/ Edema	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