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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
2
BLOCKADE MEDICAL, LLC (D.B.A. BALT USA)
SUBSTANTIALLY EQUIVALENT
1
KANEKA MEDICAL AMERICA LLC
SUBSTANTIALLY EQUIVALENT
1
KANEKA PHARMA AMERICA LLC
SUBSTANTIALLY EQUIVALENT
1
MEDOS INTERNATIONAL SARL
SUBSTANTIALLY EQUIVALENT
1
MEDOS INTERNATIONAL, SARL
SUBSTANTIALLY EQUIVALENT
1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
1
MICRO THERAPEUTICS, LNC. D/B/A EV3 NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
1
MICROPORT NEUROTECH (SHANGHAI) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
PENUMBRA, INC.
SUBSTANTIALLY EQUIVALENT
3
SPARTAN MICRO, INC
SUBSTANTIALLY EQUIVALENT
1
STRYKER NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
2
WALLABY MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
2058
2058
2019
1763
1763
2020
1753
1753
2021
2267
2267
2022
663
663
2023
513
513
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Advance
2587
2587
Physical Resistance/Sticking
2414
2414
Premature Separation
1646
1646
Material Deformation
646
646
Separation Failure
566
566
Detachment of Device or Device Component
473
473
Mechanical Problem
384
384
Break
376
376
Adverse Event Without Identified Device or Use Problem
375
375
Physical Resistance
330
330
Difficult or Delayed Separation
320
320
Fracture
235
235
Stretched
215
215
Detachment Of Device Component
208
208
Migration
202
202
Failure to Fold
183
183
Device Damaged Prior to Use
147
147
Unraveled Material
107
107
Difficult to Advance
102
102
Material Twisted/Bent
94
94
Kinked
90
90
Difficult to Remove
83
83
Device Handling Problem
82
82
Mechanical Jam
79
79
Difficult or Delayed Activation
60
60
Device Operates Differently Than Expected
54
54
Device-Device Incompatibility
52
52
Premature Activation
52
52
Migration or Expulsion of Device
50
50
Retraction Problem
47
47
Expulsion
44
44
Device Dislodged or Dislocated
36
36
Out-Of-Box Failure
36
36
Difficult or Delayed Positioning
34
34
Inadequacy of Device Shape and/or Size
32
32
Bent
29
29
Positioning Problem
26
26
No Apparent Adverse Event
26
26
Device Fell
25
25
Appropriate Term/Code Not Available
24
24
Unintended Movement
22
22
Separation Problem
22
22
Deformation Due to Compressive Stress
21
21
Positioning Failure
20
20
Activation, Positioning or Separation Problem
16
16
Component Missing
16
16
Material Protrusion/Extrusion
16
16
Fluid/Blood Leak
15
15
Insufficient Information
14
14
Device Markings/Labelling Problem
13
13
Material Separation
13
13
Material Too Rigid or Stiff
13
13
Difficult To Position
13
13
Malposition of Device
11
11
Entrapment of Device
11
11
Activation Failure
9
9
Defective Device
8
8
Patient-Device Incompatibility
7
7
Collapse
6
6
Material Frayed
6
6
Device Difficult to Setup or Prepare
5
5
Component Misassembled
5
5
Inadequate User Interface
5
5
Material Split, Cut or Torn
4
4
Activation Problem
4
4
Poor Visibility
4
4
Inaccurate Information
4
4
Device Slipped
4
4
Folded
3
3
Contamination /Decontamination Problem
3
3
Leak/Splash
3
3
Contamination
3
3
Corroded
3
3
Device Contamination with Chemical or Other Material
3
3
Material Integrity Problem
3
3
Difficult to Open or Remove Packaging Material
2
2
Noise, Audible
2
2
Physical Property Issue
2
2
Knotted
2
2
Material Fragmentation
2
2
Particulates
2
2
Chemical Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
1
1
Device Contamination with Body Fluid
1
1
Sticking
1
1
Failure to Read Input Signal
1
1
Failure to Select Signal
1
1
Material Rupture
1
1
Self-Activation or Keying
1
1
Dull, Blunt
1
1
High Sensing Threshold
1
1
Wrinkled
1
1
Biocompatibility
1
1
Peeled/Delaminated
1
1
Off-Label Use
1
1
Poor Quality Image
1
1
Unintended Collision
1
1
Unsealed Device Packaging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
5031
5031
No Clinical Signs, Symptoms or Conditions
3803
3803
No Patient Involvement
240
240
No Known Impact Or Consequence To Patient
175
175
Aneurysm
75
75
Thrombosis/Thrombus
46
46
Rupture
41
41
Thrombus
36
36
Insufficient Information
35
35
Foreign Body In Patient
33
33
Ischemia Stroke
33
33
Intracranial Hemorrhage
33
33
Headache
32
32
Ruptured Aneurysm
32
32
Stroke/CVA
29
29
Device Embedded In Tissue or Plaque
27
27
Ischemia
26
26
Hemorrhage/Bleeding
24
24
Thrombosis
23
23
Death
19
19
Thromboembolism
17
17
Obstruction/Occlusion
16
16
Vasoconstriction
14
14
Neurological Deficit/Dysfunction
14
14
Weakness
13
13
Patient Problem/Medical Problem
12
12
Muscle Weakness
12
12
Unspecified Infection
12
12
Perforation
12
12
Paresis
11
11
Hematoma
11
11
Embolism/Embolus
10
10
Stenosis
10
10
Perforation of Vessels
9
9
Infarction, Cerebral
9
9
Occlusion
9
9
Hemorrhage, Subarachnoid
9
9
Fever
8
8
Dizziness
8
8
Unspecified Nervous System Problem
8
8
Hydrocephalus
8
8
Convulsion/Seizure
8
8
No Code Available
8
8
Cerebral Edema
7
7
Swelling/ Edema
7
7
Visual Impairment
7
7
Cognitive Changes
7
7
Inflammation
7
7
Neuropathy
7
7
High Blood Pressure/ Hypertension
6
6
Transient Ischemic Attack
6
6
Cardiac Arrest
6
6
Injury
6
6
Visual Disturbances
6
6
Dysphasia
6
6
Numbness
5
5
Lethargy
5
5
No Information
5
5
Extravasation
5
5
Paralysis
5
5
Hemorrhage, Cerebral
4
4
Fistula
4
4
Foreign Body Reaction
4
4
Abscess
4
4
Hemorrhagic Stroke
4
4
Loss of Vision
4
4
Blood Loss
3
3
Cramp(s) /Muscle Spasm(s)
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Aspiration/Inhalation
3
3
Embolism
3
3
Embolus
3
3
Pain
3
3
Necrosis
3
3
Fatigue
2
2
Nausea
2
2
Failure of Implant
2
2
Shock
2
2
Pulmonary Emphysema
2
2
Hemoptysis
2
2
Bacterial Infection
2
2
Abdominal Pain
2
2
Cyst(s)
2
2
Gastrointestinal Hemorrhage
2
2
Heart Failure/Congestive Heart Failure
2
2
Vascular Dissection
2
2
Speech Disorder
2
2
Pseudoaneurysm
2
2
Coma
2
2
Great Vessel Perforation
2
2
Therapeutic Response, Decreased
2
2
Discomfort
1
1
Brain Injury
1
1
Convulsion, Clonic
1
1
Hernia
1
1
Radiation Sickness Syndrome
1
1
Vomiting
1
1
Blurred Vision
1
1
Loss of consciousness
1
1
Irritability
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BALT USA, LLC
II
Oct-20-2022
2
BALT USA, LLC
II
Sep-06-2022
3
BALT USA, LLC
II
Feb-22-2022
4
Codman & Shurtleff Inc
II
Aug-15-2019
5
Micro Therapeutics, Inc.
II
Jun-13-2022
6
Microvention, Inc.
II
Feb-27-2020
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