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	3
EXIMO MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	6
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K212027 TurboHawk Plus Directional Atherectomy System
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	887	1500
Detachment of Device or Device Component	753	998
Adverse Event Without Identified Device or Use Problem	607	1583
Entrapment of Device	521	526
Material Deformation	327	450
Material Separation	326	326
Mechanical Jam	302	303
Difficult to Remove	261	261
Physical Resistance/Sticking	260	261
Mechanical Problem	148	148
Suction Problem	123	123
Fracture	119	121
Difficult to Advance	93	93
Leak/Splash	90	90
Noise, Audible	90	90
Retraction Problem	87	87
Device Damaged by Another Device	82	82
Failure to Advance	64	64
Deformation Due to Compressive Stress	57	57
Unexpected Shutdown	47	47
Improper or Incorrect Procedure or Method	36	36
Positioning Problem	35	35
Stretched	35	35
Use of Device Problem	33	33
Overheating of Device	31	31
Defective Device	31	31
Device Markings/Labelling Problem	28	30
Device-Device Incompatibility	26	26
Fluid/Blood Leak	23	23
Material Split, Cut or Torn	22	22
Activation Problem	19	19
Melted	19	19
Intermittent Loss of Power	18	18
Off-Label Use	17	17
Material Integrity Problem	17	17
Unintended System Motion	16	16
Insufficient Information	16	16
Material Puncture/Hole	15	15
Device Contaminated at the User Facility	14	14
Peeled/Delaminated	14	14
Flushing Problem	14	14
Device Difficult to Setup or Prepare	13	13
Device Contamination with Chemical or Other Material	13	13
Difficult or Delayed Activation	13	13
Device Handling Problem	12	12
No Apparent Adverse Event	11	11
Output Problem	10	10
Display or Visual Feedback Problem	10	10
Device Displays Incorrect Message	9	9
Difficult to Insert	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2312	2929
No Consequences Or Impact To Patient	271	271
Foreign Body In Patient	249	250
Embolism/Embolus	223	467
Vascular Dissection	201	568
Perforation of Vessels	176	298
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	139	140
Device Embedded In Tissue or Plaque	96	96
Insufficient Information	85	87
Perforation	73	73
No Known Impact Or Consequence To Patient	70	192
Obstruction/Occlusion	68	68
Thrombosis/Thrombus	65	65
Unintended Radiation Exposure	64	918
Pain	43	43
Stenosis	39	39
Hemorrhage/Bleeding	32	32
Hematoma	31	31
Pseudoaneurysm	31	31
Embolism	28	150
Restenosis	26	26
Aneurysm	21	21
Unspecified Tissue Injury	20	20
Vessel Or Plaque, Device Embedded In	19	19
Radiation Exposure, Unintended	18	140
Vasoconstriction	18	18
Vascular System (Circulation), Impaired	17	17
Ischemia	15	15
Injury	14	14
Iatrogenic Source	14	14
Myocardial Infarction	13	13
Fistula	12	12
No Code Available	11	11
Rupture	10	10
Extravasation	9	9
Occlusion	7	7
Low Blood Pressure/ Hypotension	7	7
Renal Failure	7	7
Thromboembolism	6	6
Cardiac Arrest	6	6
Intimal Dissection	6	6
Stroke/CVA	6	6
Reocclusion	6	6
Swelling/ Edema	5	5
Sepsis	5	5
Hypersensitivity/Allergic reaction	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