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TPLC
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Device
catheter, peripheral, atherectomy
Product Code
MCW
Regulation Number
870.4875
Device Class
2
Premarket Reviews
Manufacturer
Decision
AVINGER, INC.
SUBSTANTIALLY EQUIVALENT
3
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
CARDIOVASCUALR SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
CARDIOVASCULAR SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
6
EXIMO MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
4
MEDTRONIC, INC
SUBSTANTIALLY EQUIVALENT
1
REX MEDICAL, L.P.
SUBSTANTIALLY EQUIVALENT
2
SPECTRANETICS INC.
SUBSTANTIALLY EQUIVALENT
1
SPECTRANETICS, INC.
SUBSTANTIALLY EQUIVALENT
1
STRAUB MEDICAL AG
SUBSTANTIALLY EQUIVALENT
1
VOLCANO ATHEROMED INC.
SUBSTANTIALLY EQUIVALENT
2
VOLCANO ATHEROMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
537
537
2019
618
618
2020
631
753
2021
734
2930
2022
565
565
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
530
774
Entrapment of Device
518
518
Adverse Event Without Identified Device or Use Problem
376
1352
Break
363
973
Material Separation
280
280
Material Deformation
225
347
Mechanical Problem
207
207
Difficult to Remove
190
190
Physical Resistance/Sticking
170
170
Suction Problem
148
148
Fracture
115
115
Device Damaged by Another Device
103
103
Mechanical Jam
97
97
Difficult to Advance
88
88
Noise, Audible
68
68
Use of Device Problem
65
65
Leak/Splash
46
46
Positioning Problem
39
39
Failure to Advance
32
32
Device Markings/Labelling Problem
27
27
Device-Device Incompatibility
26
26
Unexpected Shutdown
25
25
Infusion or Flow Problem
24
24
Material Integrity Problem
24
24
Material Split, Cut or Torn
23
23
Defective Device
23
23
Material Twisted/Bent
22
22
Fluid/Blood Leak
21
21
Retraction Problem
19
19
Peeled/Delaminated
19
19
Aspiration Issue
18
18
Device Operates Differently Than Expected
18
18
Material Puncture/Hole
15
15
Device Difficult to Setup or Prepare
14
14
Deformation Due to Compressive Stress
14
14
Display or Visual Feedback Problem
13
13
Device Remains Activated
13
13
Intermittent Loss of Power
13
13
Unintended System Motion
12
12
Overheating of Device
11
11
Device Contamination with Chemical or Other Material
11
11
Detachment Of Device Component
10
10
Off-Label Use
10
10
Melted
10
10
No Apparent Adverse Event
10
10
Device Displays Incorrect Message
10
10
Insufficient Information
9
9
Difficult to Open or Close
9
9
Device Operational Issue
9
9
Failure to Prime
8
8
Improper or Incorrect Procedure or Method
8
8
Missing Information
8
8
Therapeutic or Diagnostic Output Failure
8
8
Crack
8
252
Difficult or Delayed Activation
8
8
Material Rupture
8
8
Material Perforation
7
7
Activation Problem
7
7
No Flow
7
7
Output Problem
7
7
Compatibility Problem
7
7
Defective Component
6
6
Device Dislodged or Dislocated
6
6
Appropriate Term/Code Not Available
6
6
Difficult to Insert
6
6
Material Frayed
5
5
Obstruction of Flow
5
5
Stretched
5
5
Loss of or Failure to Bond
5
5
Contamination
5
5
Failure to Power Up
5
5
Material Fragmentation
5
5
Device Handling Problem
5
5
Inaccurate Information
5
5
Migration
4
4
Failure to Shut Off
4
4
Activation, Positioning or Separation Problem
4
4
Insufficient Flow or Under Infusion
4
4
Contamination /Decontamination Problem
4
4
Activation Failure
4
4
Connection Problem
3
3
Packaging Problem
3
3
Temperature Problem
3
3
Pumping Stopped
3
3
Failure to Calibrate
3
125
Device Contaminated During Manufacture or Shipping
3
3
Power Problem
3
3
Unintended Movement
3
3
Device Misassembled During Manufacturing /Shipping
2
2
Battery Problem
2
2
Energy Output Problem
2
2
Device Contamination with Body Fluid
2
2
Solder Joint Fracture
2
2
Failure to Infuse
2
2
Tear, Rip or Hole in Device Packaging
2
2
Device Stops Intermittently
2
2
Air/Gas in Device
2
2
Sparking
2
2
Patient-Device Incompatibility
2
2
Material Protrusion/Extrusion
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
958
1568
No Consequences Or Impact To Patient
911
911
Foreign Body In Patient
229
229
No Known Impact Or Consequence To Patient
177
299
Vascular Dissection
139
505
Device Embedded In Tissue or Plaque
117
117
Perforation of Vessels
109
231
Embolism
82
204
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
81
81
Insufficient Information
64
64
Patient Problem/Medical Problem
53
53
Perforation
52
52
Embolism/Embolus
50
294
No Code Available
41
41
Radiation Exposure, Unintended
40
162
Vessel Or Plaque, Device Embedded In
39
39
Injury
37
37
Unintended Radiation Exposure
36
890
Thrombosis/Thrombus
29
29
Pain
28
28
Iatrogenic Source
26
26
Vascular System (Circulation), Impaired
26
26
Obstruction/Occlusion
22
22
Occlusion
20
20
Unspecified Tissue Injury
19
19
Pseudoaneurysm
16
16
Hematoma
16
16
Thrombus
16
16
Reocclusion
15
15
Stenosis
13
13
Myocardial Infarction
12
12
Intimal Dissection
12
12
Death
12
12
Restenosis
10
10
No Patient Involvement
10
10
Rupture
9
9
Hemorrhage/Bleeding
9
9
Thrombosis
9
9
Low Blood Pressure/ Hypotension
8
8
Thromboembolism
8
8
Extravasation
8
8
Aneurysm
7
7
Embolus
7
7
Fistula
7
7
Sepsis
6
6
Ischemia
6
6
Vasoconstriction
4
4
Intraoperative Pain
4
4
Blood Loss
4
4
Peripheral Vascular Disease
4
4
Renal Failure
4
4
Hypersensitivity/Allergic reaction
3
3
Nausea
3
3
Stroke/CVA
3
3
Cardiac Arrest
3
3
Fever
3
3
Calcium Deposits/Calcification
3
3
Deformity/ Disfigurement
2
2
Foreign Body Embolism
2
2
Burning Sensation
2
2
Discomfort
2
2
Tissue Damage
2
2
Swelling/ Edema
2
2
Muscle Spasm(s)
2
2
Dyspnea
2
2
Exsanguination
1
1
Gangrene
1
1
Pulmonary Embolism
1
1
Burn(s)
1
1
Loss of consciousness
1
1
Respiratory Acidosis
1
1
Respiratory Failure
1
1
Atrial Perforation
1
1
Skin Tears
1
1
Claudication
1
1
Missing Value Reason
1
1
No Information
1
1
Great Vessel Perforation
1
1
Diminished Pulse Pressure
1
1
Bone Fracture(s)
1
1
Arrhythmia
1
1
Bradycardia
1
1
Bruise/Contusion
1
1
Anxiety
1
1
Chest Pain
1
1
Vomiting
1
1
Laceration(s)
1
1
Unspecified Kidney or Urinary Problem
1
1
Unspecified Vascular Problem
1
1
Superficial (First Degree) Burn
1
1
Cardiac Tamponade
1
1
Cardiopulmonary Arrest
1
1
Hyperplasia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardiovascular Systems Inc
II
Aug-28-2021
2
Cardiovascular Systems Inc
II
Oct-11-2018
3
Micro Therapeutics Inc, Dba Ev3 Neurovascular
II
Sep-11-2018
4
ev3 Inc.
I
Mar-07-2022
5
ev3 Inc.
I
Jan-19-2022
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