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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
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
2
PENUMBRA, INC.
SUBSTANTIALLY EQUIVALENT
2
STRYKER NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
1763
1763
2020
1753
1753
2021
2267
2267
2022
663
663
2023
569
569
2024
195
195
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
2148
2148
Failure to Advance
1965
1965
Premature Separation
1662
1662
Material Deformation
582
582
Separation Failure
476
476
Detachment of Device or Device Component
403
403
Difficult or Delayed Separation
303
303
Mechanical Problem
302
302
Adverse Event Without Identified Device or Use Problem
286
286
Fracture
255
255
Break
231
231
Migration
196
196
Stretched
179
179
Failure to Fold
143
143
Unraveled Material
93
93
Difficult to Advance
68
68
Material Twisted/Bent
64
64
Difficult to Remove
58
58
Device Damaged Prior to Use
54
54
Expulsion
52
52
Device-Device Incompatibility
34
34
Device Dislodged or Dislocated
28
28
Difficult or Delayed Positioning
25
25
Appropriate Term/Code Not Available
24
24
No Apparent Adverse Event
23
23
Migration or Expulsion of Device
21
21
Retraction Problem
19
19
Component Missing
19
19
Positioning Problem
19
19
Separation Problem
19
19
Device Fell
15
15
Fluid/Blood Leak
13
13
Device Markings/Labelling Problem
12
12
Insufficient Information
12
12
Premature Activation
11
11
Activation, Positioning or Separation Problem
10
10
Unintended Movement
10
10
Activation Failure
9
9
Entrapment of Device
9
9
Material Separation
8
8
Inadequacy of Device Shape and/or Size
6
6
Material Protrusion/Extrusion
6
6
Device Handling Problem
6
6
Component Misassembled
5
5
Inaccurate Information
5
5
Malposition of Device
5
5
Material Frayed
5
5
Collapse
4
4
Device Slipped
4
4
Device Difficult to Setup or Prepare
4
4
Deformation Due to Compressive Stress
4
4
Difficult or Delayed Activation
4
4
Poor Visibility
4
4
Material Split, Cut or Torn
4
4
Activation Problem
3
3
Contamination /Decontamination Problem
3
3
Corroded
3
3
Positioning Failure
3
3
Material Fragmentation
2
2
Unsealed Device Packaging
2
2
Material Too Rigid or Stiff
2
2
Patient-Device Incompatibility
2
2
Defective Device
2
2
Use of Device Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Inadequate User Interface
2
2
No Visual Prompts/Feedback
2
2
Noise, Audible
1
1
Mechanical Jam
1
1
Output Problem
1
1
Device Contaminated at the User Facility
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Integrity Problem
1
1
Device Damaged by Another Device
1
1
Environmental Compatibility Problem
1
1
Difficult to Open or Remove Packaging Material
1
1
Improper or Incorrect Procedure or Method
1
1
Incomplete or Missing Packaging
1
1
Tear, Rip or Hole in Device Packaging
1
1
Material Rupture
1
1
Self-Activation or Keying
1
1
Failure to Read Input Signal
1
1
Particulates
1
1
Peeled/Delaminated
1
1
Poor Quality Image
1
1
Nonstandard Device
1
1
Unintended Collision
1
1
Difficult to Insert
1
1
Unintended Ejection
1
1
Difficult to Flush
1
1
Difficult to Fold, Unfold or Collapse
1
1
Material Discolored
1
1
Electrical /Electronic Property Problem
1
1
Crack
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4014
4014
No Consequences Or Impact To Patient
3359
3359
No Known Impact Or Consequence To Patient
102
102
No Patient Involvement
82
82
Aneurysm
53
53
Thrombosis/Thrombus
50
50
Foreign Body In Patient
46
46
Insufficient Information
38
38
Ruptured Aneurysm
36
36
Ischemia Stroke
35
35
Intracranial Hemorrhage
29
29
Stroke/CVA
27
27
Rupture
26
26
Hemorrhage/Bleeding
22
22
Device Embedded In Tissue or Plaque
20
20
Thromboembolism
17
17
Headache
17
17
Obstruction/Occlusion
16
16
Vasoconstriction
13
13
Unspecified Infection
12
12
Muscle Weakness
12
12
Thrombosis
11
11
Hematoma
11
11
Hydrocephalus
11
11
Embolism/Embolus
10
10
Stenosis
10
10
Paresis
10
10
Perforation
10
10
Thrombus
9
9
Death
9
9
Perforation of Vessels
9
9
Unspecified Nervous System Problem
8
8
Convulsion/Seizure
8
8
Fever
8
8
Visual Impairment
7
7
Inflammation
7
7
Cerebral Edema
7
7
Swelling/ Edema
7
7
Cognitive Changes
7
7
Paralysis
6
6
Dysphasia
6
6
Injury
6
6
Ischemia
6
6
High Blood Pressure/ Hypertension
6
6
Cardiac Arrest
6
6
Extravasation
5
5
Loss of Vision
5
5
Neurological Deficit/Dysfunction
5
5
Patient Problem/Medical Problem
5
5
Coma
4
4
Hemorrhagic Stroke
4
4
Neuropathy
4
4
Occlusion
4
4
Visual Disturbances
4
4
Transient Ischemic Attack
4
4
Infarction, Cerebral
4
4
Abscess
4
4
Hemorrhage, Subarachnoid
4
4
Fistula
4
4
Foreign Body Reaction
4
4
Failure of Implant
3
3
Aspiration/Inhalation
3
3
Pain
3
3
Necrosis
3
3
Speech Disorder
3
3
No Code Available
3
3
Foreign Body Embolism
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Cramp(s) /Muscle Spasm(s)
3
3
Dizziness
3
3
Vascular Dissection
3
3
Blood Loss
3
3
Pseudoaneurysm
2
2
Therapeutic Response, Decreased
2
2
Loss of consciousness
2
2
Great Vessel Perforation
2
2
Gastrointestinal Hemorrhage
2
2
Heart Failure/Congestive Heart Failure
2
2
Nausea
2
2
Shock
2
2
Abdominal Pain
2
2
Pulmonary Emphysema
2
2
Hemoptysis
2
2
Cyst(s)
2
2
Fatigue
2
2
Granuloma
1
1
Hemorrhage, Cerebral
1
1
Hyperplasia
1
1
Hypersensitivity/Allergic reaction
1
1
Encephalopathy
1
1
Facial Nerve Paralysis
1
1
Chemosis
1
1
Edema
1
1
Embolism
1
1
Air Embolism
1
1
Atrial Fibrillation
1
1
Bacterial Infection
1
1
Bradycardia
1
1
Tachycardia
1
1
Optical Nerve Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BALT USA, LLC
II
Feb-08-2024
2
BALT USA, LLC
II
Oct-20-2022
3
BALT USA, LLC
II
Sep-06-2022
4
BALT USA, LLC
II
Feb-22-2022
5
Codman & Shurtleff Inc
II
Aug-15-2019
6
Micro Therapeutics, Inc.
II
Jun-13-2022
7
Microvention, Inc.
II
Feb-27-2020
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