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
	SUBSTANTIALLY EQUIVALENT	1
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	991	1604
Detachment of Device or Device Component	815	1060
Adverse Event Without Identified Device or Use Problem	709	1685
Entrapment of Device	556	561
Material Deformation	370	494
Mechanical Jam	353	354
Material Separation	343	343
Physical Resistance/Sticking	289	290
Difficult to Remove	283	283
Mechanical Problem	155	155
Fracture	128	130
Suction Problem	123	123
Noise, Audible	116	117
Difficult to Advance	99	99
Leak/Splash	94	94
Retraction Problem	90	90
Device Damaged by Another Device	85	85
Failure to Advance	75	75
Deformation Due to Compressive Stress	70	70
Unexpected Shutdown	50	50
Stretched	47	47
Improper or Incorrect Procedure or Method	38	38
Overheating of Device	37	37
Positioning Problem	35	35
Use of Device Problem	33	33
Defective Device	31	31
Device Markings/Labelling Problem	30	32
Device-Device Incompatibility	29	29
Activation Problem	29	29
Fluid/Blood Leak	24	24
Melted	24	24
Insufficient Information	23	23
Material Split, Cut or Torn	22	22
Intermittent Loss of Power	18	18
Unintended System Motion	18	18
Suction Failure	18	18
Material Integrity Problem	17	17
Flushing Problem	17	17
Off-Label Use	17	17
Material Puncture/Hole	16	16
Device Difficult to Setup or Prepare	15	15
Peeled/Delaminated	15	15
Device Contaminated at the User Facility	15	15
Device Contamination with Chemical or Other Material	14	14
Difficult or Delayed Activation	13	13
Device Handling Problem	12	12
No Apparent Adverse Event	11	11
Crack	10	254
Display or Visual Feedback Problem	10	10
Output Problem	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2563	3181
Foreign Body In Patient	272	273
No Consequences Or Impact To Patient	271	271
Embolism/Embolus	259	503
Vascular Dissection	230	597
Perforation of Vessels	190	312
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	144	145
Device Embedded In Tissue or Plaque	101	101
Insufficient Information	101	103
Obstruction/Occlusion	78	78
Thrombosis/Thrombus	75	75
Perforation	75	75
Unintended Radiation Exposure	70	924
No Known Impact Or Consequence To Patient	70	192
Pain	44	44
Stenosis	39	39
Restenosis	36	36
Hemorrhage/Bleeding	35	35
Hematoma	34	34
Pseudoaneurysm	31	31
Ischemia	30	30
Embolism	28	150
Aneurysm	24	24
Unspecified Tissue Injury	20	20
Vessel Or Plaque, Device Embedded In	19	19
Vasoconstriction	19	19
Radiation Exposure, Unintended	18	140
Vascular System (Circulation), Impaired	17	17
Myocardial Infarction	16	16
Fistula	14	14
Injury	14	14
Iatrogenic Source	14	14
No Code Available	11	11
Rupture	10	10
Extravasation	9	9
Stroke/CVA	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
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