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TPLC
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Device
catheter, continuous flush
Product Code
KRA
Regulation Number
870.1210
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABLATIVE SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
AGILE DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
ARGON MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
BALT USA, LLC
SUBSTANTIALLY EQUIVALENT
2
BEND IT TECHNOLOGIES LTD.
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
HERAEUS MEDICAL COMPONENTS, LLC
SUBSTANTIALLY EQUIVALENT
1
INSTYLLA, INC.
SUBSTANTIALLY EQUIVALENT
3
MEDOS INTERNATIONAL SARL
SUBSTANTIALLY EQUIVALENT
2
MERCATOR MEDSYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEM, INC.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
MICRO THERAPEUATICS, INC. D/B/A EV3 NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
1
SMARTWISE SWEDEN AB
SUBSTANTIALLY EQUIVALENT
1
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD
SUBSTANTIALLY EQUIVALENT
1
1. K212719
Micro Catheter and Guidewire System
TRANSIT SCIENTIFIC, LLC
SUBSTANTIALLY EQUIVALENT
1
TRISALUS LIFE SCIENCES
SUBSTANTIALLY EQUIVALENT
2
VASCUPATENT MEDICAL (SHENZHEN) CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
VVT MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
WALLABY MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
418
418
2020
381
381
2021
440
440
2022
543
543
2023
828
828
2024
266
266
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
620
620
Physical Resistance/Sticking
586
586
Break
575
575
Leak/Splash
168
168
Material Deformation
153
153
Detachment of Device or Device Component
136
136
Material Separation
119
119
Burst Container or Vessel
96
96
Fracture
85
85
Material Integrity Problem
82
82
Device Dislodged or Dislocated
74
74
Difficult to Remove
71
71
Difficult to Advance
68
68
Entrapment of Device
63
63
Device Damaged by Another Device
62
62
Material Twisted/Bent
46
46
Obstruction of Flow
40
40
Fluid/Blood Leak
34
34
Packaging Problem
31
31
Stretched
29
29
Material Perforation
28
28
Defective Device
27
27
No Apparent Adverse Event
27
27
Device Alarm System
25
25
Difficult to Open or Remove Packaging Material
24
24
Audible Prompt/Feedback Problem
18
18
Electrical /Electronic Property Problem
18
18
Failure to Advance
18
18
Material Puncture/Hole
17
17
Deformation Due to Compressive Stress
17
17
Difficult to Flush
15
15
Device Fell
14
14
Material Rupture
14
14
Collapse
14
14
Display or Visual Feedback Problem
13
13
Contamination /Decontamination Problem
13
13
Suction Problem
12
12
Compatibility Problem
12
12
Crack
12
12
Output Problem
11
11
Device Displays Incorrect Message
11
11
Unintended Movement
10
10
Peeled/Delaminated
9
9
Temperature Problem
9
9
Material Split, Cut or Torn
9
9
Contamination
7
7
Positioning Problem
7
7
Difficult to Insert
6
6
Separation Problem
6
6
Device Contaminated During Manufacture or Shipping
6
6
Unsealed Device Packaging
6
6
Device Difficult to Setup or Prepare
6
6
Activation, Positioning or Separation Problem
5
5
Appropriate Term/Code Not Available
5
5
Connection Problem
5
5
Material Frayed
5
5
Device Markings/Labelling Problem
5
5
Material Too Soft/Flexible
4
4
Device Contamination with Chemical or Other Material
4
4
Tear, Rip or Hole in Device Packaging
4
4
Migration or Expulsion of Device
4
4
Use of Device Problem
3
3
Separation Failure
3
3
Mechanical Jam
3
3
Disconnection
3
3
Difficult or Delayed Activation
3
3
Unable to Obtain Readings
2
2
Sharp Edges
2
2
Device-Device Incompatibility
2
2
Loss of or Failure to Bond
2
2
Therapeutic or Diagnostic Output Failure
2
2
Backflow
2
2
Priming Problem
2
2
Infusion or Flow Problem
2
2
Human-Device Interface Problem
2
2
Failure to Prime
1
1
Patient-Device Incompatibility
1
1
Product Quality Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Poor Visibility
1
1
Inappropriate or Unexpected Reset
1
1
Delivered as Unsterile Product
1
1
Activation Problem
1
1
Incorrect Measurement
1
1
Retraction Problem
1
1
Component Missing
1
1
Signal Artifact/Noise
1
1
Deflation Problem
1
1
Pressure Problem
1
1
Off-Label Use
1
1
Device Emits Odor
1
1
Complete Blockage
1
1
Unexpected Shutdown
1
1
Incomplete or Missing Packaging
1
1
Device Handling Problem
1
1
Failure to Power Up
1
1
Moisture Damage
1
1
Thermal Decomposition of Device
1
1
Defective Alarm
1
1
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1364
1364
No Consequences Or Impact To Patient
370
370
No Known Impact Or Consequence To Patient
191
191
Intracranial Hemorrhage
183
183
Foreign Body In Patient
121
121
Insufficient Information
115
115
Hemorrhage/Bleeding
101
101
Stroke/CVA
67
67
Device Embedded In Tissue or Plaque
64
64
Unspecified Nervous System Problem
60
60
Vasoconstriction
57
57
No Patient Involvement
49
49
Thrombosis/Thrombus
48
48
Obstruction/Occlusion
48
48
Hematoma
47
47
Thromboembolism
46
46
Ischemia Stroke
39
39
Vascular Dissection
38
38
Ischemia
38
38
No Code Available
36
36
Rupture
36
36
Embolism/Embolus
35
35
Swelling/ Edema
33
33
Stenosis
30
30
Paresis
25
25
Perforation of Vessels
24
24
Pain
21
21
Headache
20
20
Death
19
19
Muscle Weakness
19
19
Pseudoaneurysm
19
19
Dysphasia
18
18
Hydrocephalus
15
15
Convulsion/Seizure
15
15
Paralysis
15
15
Unspecified Infection
15
15
Perforation
14
14
Fistula
14
14
Transient Ischemic Attack
13
13
Visual Disturbances
13
13
Failure of Implant
12
12
Low Blood Pressure/ Hypotension
11
11
Coma
11
11
Confusion/ Disorientation
10
10
Cardiac Arrest
10
10
Aneurysm
9
9
Arrhythmia
9
9
Cognitive Changes
9
9
Renal Failure
9
9
Blood Loss
8
8
Hemorrhagic Stroke
8
8
Pulmonary Embolism
8
8
Nerve Damage
8
8
Respiratory Insufficiency
8
8
Heart Failure/Congestive Heart Failure
7
7
Unintended Radiation Exposure
7
7
Nausea
7
7
Bradycardia
7
7
Dyspnea
7
7
Ruptured Aneurysm
7
7
Blurred Vision
7
7
Visual Impairment
7
7
Loss of Vision
7
7
Thrombus
6
6
Respiratory Failure
6
6
Post Operative Wound Infection
5
5
Dizziness
5
5
Skin Discoloration
5
5
Speech Disorder
5
5
Chest Pain
5
5
Fatigue
5
5
High Blood Pressure/ Hypertension
5
5
Hypersensitivity/Allergic reaction
4
4
Hemorrhage, Subarachnoid
4
4
Fever
4
4
Encephalopathy
4
4
Infarction, Cerebral
4
4
Abdominal Pain
4
4
Aspiration/Inhalation
4
4
Syncope/Fainting
4
4
Cerebral Edema
4
4
Nervous System Injury
4
4
Sepsis
4
4
Thrombosis
3
3
Vomiting
3
3
Paraplegia
3
3
Numbness
3
3
Atrial Fibrillation
3
3
Bacterial Infection
3
3
Abscess
3
3
Anemia
3
3
Foreign Body Reaction
3
3
Granuloma
3
3
Hemorrhage, Cerebral
3
3
Myocardial Infarction
3
3
Neuropathy
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Retroperitoneal Hemorrhage
3
3
Cramp(s) /Muscle Spasm(s)
3
3
Restenosis
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Angiodynamics, Inc.
II
Feb-07-2024
2
Boston Scientific Corporation
II
Dec-17-2020
3
Cook Inc.
I
Dec-09-2019
4
Merit Medical Systems, Inc.
II
Jan-02-2024
5
Micro Therapeutics, Inc.
II
Aug-18-2022
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