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
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	905	1518
Detachment of Device or Device Component	767	1012
Adverse Event Without Identified Device or Use Problem	624	1600
Entrapment of Device	525	530
Material Deformation	335	459
Material Separation	326	326
Mechanical Jam	310	311
Physical Resistance/Sticking	265	266
Difficult to Remove	264	264
Mechanical Problem	152	152
Suction Problem	123	123
Fracture	122	124
Difficult to Advance	95	95
Noise, Audible	93	94
Leak/Splash	90	90
Retraction Problem	88	88
Device Damaged by Another Device	83	83
Failure to Advance	65	65
Deformation Due to Compressive Stress	57	57
Unexpected Shutdown	47	47
Improper or Incorrect Procedure or Method	36	36
Stretched	36	36
Positioning Problem	35	35
Overheating of Device	35	35
Use of Device Problem	33	33
Defective Device	31	31
Device Markings/Labelling Problem	28	30
Device-Device Incompatibility	26	26
Fluid/Blood Leak	23	23
Insufficient Information	22	22
Material Split, Cut or Torn	22	22
Melted	20	20
Activation Problem	19	19
Intermittent Loss of Power	18	18
Material Integrity Problem	17	17
Off-Label Use	17	17
Unintended System Motion	16	16
Material Puncture/Hole	15	15
Peeled/Delaminated	14	14
Flushing Problem	14	14
Device Contaminated at the User Facility	14	14
Device Contamination with Chemical or Other Material	13	13
Device Difficult to Setup or Prepare	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
Difficult to Insert	9	9
Air/Gas in Device	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2351	2969
No Consequences Or Impact To Patient	271	271
Foreign Body In Patient	254	255
Embolism/Embolus	225	469
Vascular Dissection	207	574
Perforation of Vessels	178	300
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	140	141
Device Embedded In Tissue or Plaque	96	96
Insufficient Information	85	87
Perforation	74	74
No Known Impact Or Consequence To Patient	70	192
Obstruction/Occlusion	68	68
Thrombosis/Thrombus	67	67
Unintended Radiation Exposure	64	918
Pain	43	43
Stenosis	39	39
Hemorrhage/Bleeding	34	34
Hematoma	32	32
Pseudoaneurysm	31	31
Embolism	28	150
Restenosis	27	27
Ischemia	24	24
Aneurysm	21	21
Unspecified Tissue Injury	20	20
Vessel Or Plaque, Device Embedded In	19	19
Vasoconstriction	18	18
Radiation Exposure, Unintended	18	140
Vascular System (Circulation), Impaired	17	17
Myocardial Infarction	14	14
Iatrogenic Source	14	14
Injury	14	14
Fistula	12	12
No Code Available	11	11
Rupture	10	10
Extravasation	9	9
Stroke/CVA	8	8
Occlusion	7	7
Low Blood Pressure/ Hypotension	7	7
Renal Failure	7	7
Intimal Dissection	6	6
Thromboembolism	6	6
Cardiac Arrest	6	6
Reocclusion	6	6
Hypersensitivity/Allergic reaction	5	5
Swelling/ Edema	5	5
Sepsis	5	5
Foreign Body Embolism	4	4
Intraoperative Pain	4	4
Unspecified Infection	3	3
Blood Loss	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