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TPLC
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Device
filter, intravascular, cardiovascular
Product Code
DTK
Regulation Number
870.3375
Device Class
2
Premarket Reviews
Manufacturer
Decision
NOVATE MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
2
WILLIAM COOK EUROPE APS
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
3938
3938
2019
6467
6474
2020
5404
5404
2021
5357
5516
2022
2191
2196
2023
398
398
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
5605
5605
Appropriate Term/Code Not Available
5018
5018
Structural Problem
4695
4695
Difficult to Remove
3909
3917
Unintended Movement
2645
2644
Malposition of Device
2609
2661
Device Tipped Over
2369
2369
Patient Device Interaction Problem
2234
2287
Detachment of Device or Device Component
1910
1920
Adverse Event Without Identified Device or Use Problem
1889
1889
Fracture
1657
1657
Migration or Expulsion of Device
1392
1395
Failure to Align
1385
1385
Obstruction of Flow
1350
1350
Patient-Device Incompatibility
1344
1445
Migration
1037
1039
Positioning Problem
610
612
Entrapment of Device
324
324
Inadequate Filtration Process
321
321
Material Deformation
314
316
Activation Failure
281
281
Extrusion
159
159
Therapeutic or Diagnostic Output Failure
123
123
Break
119
119
Material Perforation
117
117
Activation, Positioning or Separation Problem
106
106
Failure to Advance
103
103
Difficult or Delayed Activation
101
101
Material Twisted/Bent
85
85
Improper or Incorrect Procedure or Method
78
78
Difficult to Advance
59
59
Defective Device
55
55
Material Puncture/Hole
47
47
Premature Activation
46
46
Positioning Failure
42
42
Activation Problem
40
40
Occlusion Within Device
36
36
Device Dislodged or Dislocated
35
35
Difficult to Insert
34
34
Material Separation
32
32
Deformation Due to Compressive Stress
32
32
Physical Resistance/Sticking
30
30
Retraction Problem
29
29
Defective Component
27
27
Difficult to Open or Close
27
27
Output Problem
22
22
Material Fragmentation
21
21
Complete Blockage
21
21
Difficult or Delayed Positioning
20
20
Material Split, Cut or Torn
16
16
Material Protrusion/Extrusion
12
12
Difficult or Delayed Separation
11
11
Unexpected Therapeutic Results
11
11
Partial Blockage
10
10
Material Frayed
9
9
Off-Label Use
9
9
Failure to Unfold or Unwrap
8
8
Coagulation in Device or Device Ingredient
8
8
Detachment Of Device Component
8
8
Device Misassembled During Manufacturing /Shipping
8
8
Device-Device Incompatibility
7
7
Sharp Edges
7
7
No Apparent Adverse Event
7
7
Collapse
7
7
Bent
7
7
Use of Device Problem
6
6
Therapy Delivered to Incorrect Body Area
5
5
Component Missing
5
5
Crack
5
5
Loss of or Failure to Bond
5
5
Mechanical Problem
5
5
Device Contamination with Chemical or Other Material
5
5
Device Operates Differently Than Expected
5
5
Connection Problem
4
4
Mechanical Jam
4
4
Loose or Intermittent Connection
4
4
Misassembled
4
4
Difficult to Fold, Unfold or Collapse
4
4
Component Incompatible
4
4
Tear, Rip or Hole in Device Packaging
4
4
Inadequacy of Device Shape and/or Size
3
3
Material Erosion
3
3
Disconnection
3
3
Peeled/Delaminated
3
3
Kinked
3
3
Protective Measures Problem
3
3
Device Damaged by Another Device
3
3
Premature Separation
3
3
Separation Problem
2
2
Device Or Device Fragments Location Unknown
2
2
Impedance Problem
2
2
Material Integrity Problem
2
2
Filling Problem
2
2
Device Inoperable
2
2
Unraveled Material
2
2
Nonstandard Device
2
2
Fitting Problem
2
2
Split
2
2
Dent in Material
2
2
Expiration Date Error
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Perforation of Vessels
8597
8597
No Information
5765
5765
Internal Organ Perforation
4410
4410
Pain
2719
2719
Perforation
2539
2539
No Consequences Or Impact To Patient
2104
2111
Anxiety
2077
2077
Pulmonary Embolism
1818
1820
No Clinical Signs, Symptoms or Conditions
1749
1921
Thrombosis
1719
1719
Insufficient Information
1646
1646
Abdominal Pain
1451
1451
Vessel Or Plaque, Device Embedded In
1446
1446
Occlusion
1034
1034
Thrombosis/Thrombus
937
937
Device Embedded In Tissue or Plaque
900
900
Stenosis
739
739
Depression
733
733
Coagulation Disorder
680
680
Chest Pain
606
606
Dyspnea
580
580
No Code Available
579
579
Thrombus
523
523
No Known Impact Or Consequence To Patient
448
448
Death
379
380
Injury
373
373
Great Vessel Perforation
359
359
Obstruction/Occlusion
331
331
Swelling
254
254
Foreign Body In Patient
250
250
Embolus
215
215
Hemorrhage/Bleeding
168
168
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
158
158
Numbness
154
154
Discomfort
153
153
Failure of Implant
141
141
Cardiac Perforation
115
115
Swelling/ Edema
111
111
Emotional Changes
102
102
Distress
98
98
Ambulation Difficulties
95
95
Bowel Perforation
91
91
Unspecified Tissue Injury
86
85
Blood Loss
82
82
Hematoma
76
76
Fatigue
67
67
Embolism
62
62
Thromboembolism
56
56
Disability
54
54
Edema
52
52
Nausea
50
50
Vascular System (Circulation), Impaired
48
48
Pericardial Effusion
45
45
Unspecified Mental, Emotional or Behavioural Problem
45
45
Stroke/CVA
39
39
Cognitive Changes
38
38
Sleep Dysfunction
37
37
Embolism/Embolus
33
33
Dizziness
32
32
Peripheral Edema
29
29
Scar Tissue
27
27
Loss of Vision
26
26
Myocardial Infarction
25
25
Headache
25
25
Cardiac Arrest
24
24
High Blood Pressure/ Hypertension
23
23
Unspecified Infection
23
23
Cramp(s) /Muscle Spasm(s)
22
22
Cardiac Tamponade
22
22
Abdominal Cramps
22
22
Scarring
21
21
Low Blood Pressure/ Hypotension
21
21
Weakness
20
20
Hematuria
20
20
Patient Problem/Medical Problem
19
19
Pseudoaneurysm
18
18
Extravasation
18
18
Erosion
17
17
Foreign Body Embolism
17
17
Bone Fracture(s)
16
16
Tachycardia
16
16
Sepsis
16
16
Renal Failure
16
16
Inflammation
16
16
Nerve Damage
15
15
Aneurysm
15
15
Cellulitis
15
15
Calcium Deposits/Calcification
15
15
Muscle Weakness
14
14
Weight Changes
14
14
Transient Ischemic Attack
13
13
Cramp(s)
13
13
Ulcer
12
12
Palpitations
11
11
Vomiting
11
11
Neuropathy
11
11
Memory Loss/Impairment
11
11
Arrhythmia
11
11
Anemia
10
10
Sexual Dysfunction
10
10
Recalls
Manufacturer
Recall Class
Date Posted
1
Argon Medical Devices, Inc
II
Jul-27-2023
2
Cook Medical Incorporated
III
Apr-06-2022
3
Cook Medical Incorporated
III
Mar-19-2019
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