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TPLC
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Device
filter, intravascular, cardiovascular
Regulation Description
Cardiovascular intravascular filter.
Product Code
DTK
Regulation Number
870.3375
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALN IMPLANTS CHIRURGICAUX
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
1
COOK, INC.
SUBSTANTIALLY EQUIVALENT
1
WILLIAM COOK
SUBSTANTIALLY EQUIVALENT
3
WILLIAM COOK EUROPE APS
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2016
2575
2575
2017
4361
4361
2018
3936
3936
2019
6466
6466
2020
5404
5404
2021
1793
1793
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
8668
8668
Difficult to Remove
5609
5609
Appropriate Term/Code Not Available
4625
4625
Filter
3177
3177
Malposition of Device
2988
2988
Adverse Event Without Identified Device or Use Problem
2535
2535
Unintended Movement
2522
2522
Migration or Expulsion of Device
2246
2246
Patient Device Interaction Problem
2225
2225
Structural Problem
1978
1978
Fracture
1941
1941
Failure to Align
1556
1556
Detachment of Device or Device Component
1498
1498
Device Tipped Over
809
809
Migration
680
680
Obstruction of Flow
584
584
Positioning Problem
519
519
Extrusion
492
492
Entrapment of Device
387
387
Material Deformation
220
220
Activation Failure
204
204
Occlusion Within Device
162
162
Activation, Positioning or SeparationProblem
151
151
Material Perforation
137
137
Break
124
124
Failure to Advance
115
115
Inadequate Filtration Process
114
114
Patient-Device Incompatibility
101
101
Difficult or Delayed Positioning
100
100
Positioning Failure
89
89
Material Separation
87
87
Material Twisted/Bent
72
72
Difficult to Advance
72
72
Kinked
71
71
Detachment Of Device Component
71
71
Premature Activation
64
64
Therapeutic or Diagnostic Output Failure
61
61
Material Puncture/Hole
59
59
Difficult or Delayed Activation
57
57
Complete Blockage
44
44
Device Operates Differently Than Expected
44
44
Material Fragmentation
39
39
Bent
38
38
Defective Device
38
38
Device Dislodged or Dislocated
36
36
Catheter
28
28
Defective Component
28
28
Difficult to Insert
28
28
Improper or Incorrect Procedure or Method
24
24
Difficult to Open or Close
24
24
Retraction Problem
24
24
Device Handling Problem
23
23
Activation Problem
19
19
Material Frayed
18
18
Physical Resistance/Sticking
18
18
Tip
17
17
Material Protrusion/Extrusion
15
15
Material Erosion
14
14
Material Split, Cut or Torn
12
12
Wire
11
11
Sticking
11
11
Difficult or Delayed Separation
10
10
Torn Material
10
10
Failure to Unfold or Unwrap
10
10
Collapse
10
10
Device Difficult to Setup or Prepare
9
9
Use of Device Problem
9
9
Split
9
9
Filtration Problem
9
9
Deformation Due to Compressive Stress
8
8
Device Issue
8
8
Therapy Delivered to Incorrect Body Area
8
8
Partial Blockage
8
8
Sharp Edges
7
7
Difficult To Position
7
7
Crack
7
7
Device Or Device Fragments Location Unknown
6
6
Cannula Guide
6
6
Hub
6
6
Leak/Splash
6
6
Loose or Intermittent Connection
6
6
Unexpected Therapeutic Results
6
6
Shaft
5
5
Failure to Capture
5
5
Coagulation in Device or Device Ingredient
5
5
Material Distortion
5
5
Expulsion
5
5
Stent
5
5
No Apparent Adverse Event
5
5
Mechanical Problem
4
4
Component or Accessory Incompatibility
4
4
Device Damaged by Another Device
4
4
Material Integrity Problem
4
4
Device Contamination with Chemical or Other Material
4
4
Premature Separation
3
3
Balloon
3
3
Failure To Adhere Or Bond
3
3
Difficult to Fold, Unfold or Collapse
3
3
Device Inoperable
3
3
Fitting Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Information
8685
8685
Perforation of Vessels
7503
7503
Internal Organ Perforation
3525
3525
Pain
3100
3100
No Consequences Or Impact To Patient
2848
2848
Vessel Or Plaque, Device Embedded In
2515
2515
Thrombosis
2347
2347
Perforation
2257
2257
Pulmonary Embolism
1963
1964
Anxiety
1728
1728
No Known Impact Or Consequence To Patient
1455
1455
Occlusion
1379
1379
Abdominal Pain
1110
1110
No Code Available
1021
1021
Injury
981
981
Thrombus
802
802
Chest Pain
731
731
Death
593
594
Great Vessel Perforation
583
583
Dyspnea
568
568
Coagulation Disorder
567
567
Device Embedded In Tissue or Plaque
545
545
Swelling
445
445
Stenosis
441
441
Depression
330
330
Embolus
257
257
Foreign Body In Patient
224
224
Blood Loss
170
170
Hemorrhage/Bleeding
163
163
No Clinical Signs, Symptoms or Conditions
130
130
Hematoma
108
108
Failure of Implant
106
106
Numbness
99
99
Cardiac Perforation
97
97
Edema
96
96
Vascular System (Circulation), Impaired
94
94
Embolism
92
92
Disability
78
78
Emotional Changes
72
72
Bowel Perforation
69
69
Scarring
69
69
Obstruction/Occlusion
67
67
Discomfort
60
60
Distress
59
59
Thromboembolism
53
53
Fatigue
52
52
Pericardial Effusion
47
47
Nausea
42
42
Stroke/CVA
40
40
Unspecified Infection
38
38
Ambulation Difficulties
38
38
Weakness
35
35
Dizziness
34
34
Thrombosis/Thrombus
33
33
Cardiac Arrest
32
32
Insufficient Information
31
31
Cramp(s)
26
26
Headache
25
25
Bone Fracture(s)
24
24
No Patient Involvement
24
24
Sepsis
24
24
Renal Failure
22
22
Hematuria
22
22
Cardiac Tamponade
21
21
Extravasation
21
21
Erosion
21
21
Patient Problem/Medical Problem
21
21
Pseudoaneurysm
20
20
Sleep Dysfunction
20
20
Abdominal Cramps
20
20
High Blood Pressure/ Hypertension
19
19
Calcium Deposits/Calcification
18
18
Aneurysm
18
18
Palpitations
18
18
Atrial Fibrillation
18
18
Arrhythmia
18
18
Myocardial Infarction
18
18
Tachycardia
18
18
Inflammation
17
17
Ulcer
16
16
Chest Tightness/Pressure
16
16
Vomiting
15
15
Respiratory Distress
15
15
Scar Tissue
15
15
Cellulitis
15
15
Low Blood Pressure/ Hypotension
15
15
Transient Ischemic Attack
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
14
14
Tissue Damage
14
14
Aspiration/Inhalation
13
13
Syncope
12
12
Anemia
11
11
Ventricular Tachycardia
11
11
Atrial Perforation
10
10
Bacterial Infection
10
10
Nerve Damage
10
10
Heart Failure
10
10
Tingling
9
9
Complaint, Ill-Defined
9
9
Seizures
9
9
Recalls
Manufacturer
Recall Class
Date Posted
1
Bard Peripheral Vascular Inc
II
Mar-08-2016
2
Bard Peripheral Vascular Inc
II
Feb-01-2016
3
Cook Medical Incorporated
III
Mar-19-2019
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