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TPLC
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Device
device, neurovascular embolization
Product Code
HCG
Regulation Number
882.5950
Device Class
2
Premarket Reviews
Manufacturer
Decision
BALT USA, LLC
SUBSTANTIALLY EQUIVALENT
1
BLOCKADE MEDICAL, LLC (D.B.A. BALT USA)
SUBSTANTIALLY EQUIVALENT
1
CODMAN & SHURTLEFF, INC
SUBSTANTIALLY EQUIVALENT
1
CODMAN & SHURTLEFF, INC.
SUBSTANTIALLY EQUIVALENT
1
KANEKA MEDICAL AMERICA LLC
SUBSTANTIALLY EQUIVALENT
1
KANEKA PHARMA AMERICA LLC
SUBSTANTIALLY EQUIVALENT
1
MEDOS INTERNATIONAL SARL
SUBSTANTIALLY EQUIVALENT
1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
2
MICROPORT NEUROTECH (SHANGHAI) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MICROVENTION, INC
SUBSTANTIALLY EQUIVALENT
1
PENUMBRA, INC.
SUBSTANTIALLY EQUIVALENT
3
SPARTAN MICRO, INC
SUBSTANTIALLY EQUIVALENT
1
STRYKER NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
1
WALLABY MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
2494
2494
2018
2058
2058
2019
1763
1763
2020
1753
1753
2021
2267
2267
2022
311
311
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Advance
3243
3243
Physical Resistance/Sticking
2271
2271
Premature Separation
1193
1193
Physical Resistance
1078
1078
Separation Failure
687
687
Material Deformation
635
635
Adverse Event Without Identified Device or Use Problem
601
601
Detachment Of Device Component
583
583
Mechanical Problem
481
481
Break
465
465
Detachment of Device or Device Component
438
438
Stretched
360
360
Difficult or Delayed Separation
269
269
Kinked
267
267
Device Handling Problem
211
211
Device Operates Differently Than Expected
208
208
Device Damaged Prior to Use
202
202
Mechanical Jam
191
191
Failure to Fold
180
180
Premature Activation
176
176
Fracture
166
166
Difficult to Advance
158
158
Migration
151
151
Positioning Failure
132
132
Migration or Expulsion of Device
119
119
Unraveled Material
116
116
Difficult or Delayed Activation
110
110
Difficult to Remove
109
109
Bent
97
97
Retraction Problem
94
94
Material Twisted/Bent
93
93
Out-Of-Box Failure
90
90
Device-Device Incompatibility
78
78
Difficult To Position
54
54
Material Protrusion/Extrusion
47
47
Inadequacy of Device Shape and/or Size
44
44
Difficult or Delayed Positioning
43
43
Appropriate Term/Code Not Available
43
43
Device Dislodged or Dislocated
35
35
Deformation Due to Compressive Stress
31
31
Unintended Movement
31
31
Material Separation
31
31
Positioning Problem
29
29
Device Fell
25
25
Entrapment of Device
25
25
Material Too Rigid or Stiff
22
22
Separation Problem
22
22
Expulsion
22
22
Activation, Positioning or SeparationProblem
22
22
Defective Device
21
21
Insufficient Information
20
20
Device Markings/Labelling Problem
16
16
Malposition of Device
15
15
Fluid Leak
15
15
No Apparent Adverse Event
12
12
Patient-Device Incompatibility
11
11
Component Missing
11
11
Material Integrity Problem
9
9
Material Frayed
8
8
Difficult to Insert
7
7
Device Difficult to Setup or Prepare
7
7
Collapse
6
6
Activation Failure
6
6
Component Misassembled
5
5
Inadequate User Interface
5
5
Difficult to Open or Remove Packaging Material
4
4
Device Damaged by Another Device
4
4
Material Split, Cut or Torn
4
4
Noise, Audible
4
4
Knotted
4
4
Device Slipped
4
4
Defective Component
4
4
Tear, Rip or Hole in Device Packaging
3
3
Folded
3
3
Sticking
3
3
Leak/Splash
3
3
Unsealed Device Packaging
3
3
Contamination
3
3
Unintended Ejection
3
3
Activation Problem
3
3
Contamination /Decontamination Problem
3
3
Device Contamination with Chemical or Other Material
3
3
Physical Property Issue
3
3
Chemical Problem
2
2
Device Operational Issue
2
2
Electrical Overstress
2
2
Crack
2
2
Accessory Incompatible
2
2
Misconnection
2
2
Looping
2
2
Material Fragmentation
2
2
Use of Device Problem
2
2
Off-Label Use
2
2
Peeled/Delaminated
2
2
Split
2
2
Dull, Blunt
1
1
Incomplete or Missing Packaging
1
1
Device Contamination with Body Fluid
1
1
Wrinkled
1
1
High Sensing Threshold
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
6888
6888
No Clinical Signs, Symptoms or Conditions
3071
3071
No Patient Involvement
377
377
No Known Impact Or Consequence To Patient
297
297
Headache
124
124
Aneurysm
100
100
Thrombus
78
78
Neurological Deficit/Dysfunction
61
61
Rupture
48
48
Thrombosis
47
47
Ischemia
40
40
Death
40
40
Hemorrhage, Subarachnoid
37
37
Weakness
37
37
Visual Disturbances
36
36
Stroke/CVA
35
35
Device Embedded In Tissue or Plaque
31
31
Hemorrhage/Bleeding
30
30
Infarction, Cerebral
28
28
Hemorrhage, Cerebral
26
26
Reaction
25
25
Ischemia Stroke
22
22
Thrombosis/Thrombus
21
21
Foreign Body In Patient
21
21
Thromboembolism
20
20
Intracranial Hemorrhage
20
20
Insufficient Information
19
19
Vasoconstriction
17
17
Ruptured Aneurysm
16
16
No Code Available
16
16
Transient Ischemic Attack
15
15
Patient Problem/Medical Problem
14
14
Unspecified Infection
13
13
Occlusion
13
13
No Information
12
12
Perforation of Vessels
12
12
Vomiting
12
12
Injury
11
11
Hydrocephalus
11
11
Nausea
11
11
Fever
11
11
Inflammation
10
10
Paresis
10
10
Perforation
10
10
Hematoma
9
9
Pain
8
8
Vitreous Floaters
8
8
Embolism
8
8
Dizziness
8
8
Dysphasia
7
7
Visual Impairment
7
7
Embolus
7
7
Foreign Body Reaction
6
6
Extravasation
6
6
High Blood Pressure/ Hypertension
6
6
Convulsion/Seizure
6
6
Lethargy
6
6
Blood Loss
5
5
Embolism/Embolus
5
5
Cognitive Changes
5
5
Obstruction/Occlusion
5
5
Neck Pain
5
5
Muscle Weakness
5
5
Abscess
5
5
Abdominal Pain
4
4
Neuropathy
4
4
Liver Damage/Dysfunction
4
4
Numbness
4
4
Stenosis
4
4
Vascular System (Circulation), Impaired
4
4
Cramp(s) /Muscle Spasm(s)
3
3
Therapeutic Response, Decreased
3
3
Hemoptysis
3
3
Necrosis
3
3
Fatigue
3
3
Edema
3
3
Cardiac Arrest
2
2
Pulmonary Emphysema
2
2
Chest Pain
2
2
Diarrhea
2
2
Bacterial Infection
2
2
Low Blood Pressure/ Hypotension
2
2
Brain Injury
2
2
Swelling/ Edema
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Gastrointestinal Hemorrhage
2
2
Unspecified Nervous System Problem
2
2
Cerebral Edema
2
2
Ascites
2
2
Toxicity
2
2
Vaso-Vagal Response
1
1
Decreased Sensitivity
1
1
Multiple Organ Failure
1
1
Nervous System Injury
1
1
Vascular Dissection
1
1
Constipation
1
1
Foreign Body Embolism
1
1
Cough
1
1
Respiratory Insufficiency
1
1
Convulsion, Clonic
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BALT USA, LLC
II
Feb-22-2022
2
Codman & Shurtleff Inc
II
Aug-15-2019
3
Micro Therapeutics, Inc.
II
Jun-13-2022
4
Microvention, Inc.
II
Feb-27-2020
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