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TPLC
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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
MDR Year
MDR Reports
MDR Events
2020
631
753
2021
734
2930
2022
566
566
2023
575
575
2024
679
679
2025
261
261
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
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