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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
1
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 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
680
680
2025
48
48
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
689
1299
Detachment of Device or Device Component
603
847
Adverse Event Without Identified Device or Use Problem
520
1496
Entrapment of Device
450
450
Material Separation
270
270
Material Deformation
257
379
Physical Resistance/Sticking
227
227
Difficult to Remove
218
218
Mechanical Jam
193
193
Mechanical Problem
140
140
Fracture
110
110
Suction Problem
107
107
Difficult to Advance
78
78
Noise, Audible
74
74
Device Damaged by Another Device
70
70
Leak/Splash
61
61
Retraction Problem
60
60
Failure to Advance
48
48
Positioning Problem
34
34
Unexpected Shutdown
33
33
Use of Device Problem
31
31
Improper or Incorrect Procedure or Method
27
27
Device Markings/Labelling Problem
27
27
Defective Device
25
25
Deformation Due to Compressive Stress
22
22
Overheating of Device
22
22
Stretched
20
20
Fluid/Blood Leak
19
19
Material Integrity Problem
17
17
Device-Device Incompatibility
16
16
Material Split, Cut or Torn
15
15
Off-Label Use
15
15
Material Puncture/Hole
14
14
Intermittent Loss of Power
14
14
Difficult or Delayed Activation
13
13
Peeled/Delaminated
13
13
Device Difficult to Setup or Prepare
13
13
Melted
13
13
Device Contamination with Chemical or Other Material
12
12
Activation Problem
12
12
No Apparent Adverse Event
11
11
Insufficient Information
11
11
Flushing Problem
10
10
Device Handling Problem
9
9
Device Displays Incorrect Message
9
9
Display or Visual Feedback Problem
9
9
Missing Information
8
8
Difficult to Insert
8
8
Infusion or Flow Problem
8
8
Therapeutic or Diagnostic Output Failure
8
8
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1821
2431
No Consequences Or Impact To Patient
271
271
Foreign Body In Patient
216
216
Vascular Dissection
188
554
Embolism/Embolus
182
426
Perforation of Vessels
143
265
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
130
130
Device Embedded In Tissue or Plaque
88
88
Insufficient Information
79
79
Perforation
70
70
No Known Impact Or Consequence To Patient
70
192
Unintended Radiation Exposure
58
912
Thrombosis/Thrombus
54
54
Stenosis
36
36
Obstruction/Occlusion
36
36
Pain
34
34
Hematoma
29
29
Embolism
28
150
Pseudoaneurysm
28
28
Hemorrhage/Bleeding
24
24
Restenosis
20
20
Unspecified Tissue Injury
20
20
Aneurysm
19
19
Vessel Or Plaque, Device Embedded In
19
19
Radiation Exposure, Unintended
18
140
Vascular System (Circulation), Impaired
17
17
Vasoconstriction
16
16
Iatrogenic Source
14
14
Injury
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
Intimal Dissection
6
6
Renal Failure
6
6
Reocclusion
6
6
Low Blood Pressure/ Hypotension
6
6
Thromboembolism
6
6
Sepsis
5
5
Stroke/CVA
5
5
Swelling/ Edema
5
5
Intraoperative Pain
4
4
Hypersensitivity/Allergic reaction
4
4
Foreign Body Embolism
4
4
Nausea
3
3
Blood Loss
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Angiodynamics, Inc.
II
Dec-27-2024
2
Cardiovascular Systems Inc
II
Aug-28-2021
3
Spectranetics Corporation
II
Dec-16-2024
4
Spectranetics Corporation
II
Dec-08-2023
5
ev3 Inc.
I
Mar-07-2022
6
ev3 Inc.
I
Jan-19-2022
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