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TPLC
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Device
wire, guide, catheter
Product Code
DQX
Regulation Number
870.1330
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT VASCULAR
SUBSTANTIALLY EQUIVALENT
3
ASAHI INTECC CO., LTD.
SUBSTANTIALLY EQUIVALENT
8
BAYLIS MEDICAL COMPANY INC.
SUBSTANTIALLY EQUIVALENT
2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
BIOMERICS NLE
SUBSTANTIALLY EQUIVALENT
1
BRIVANT LIMITED (LAKE REGION MEDICAL)
SUBSTANTIALLY EQUIVALENT
1
CARDIO FLOW, INC.
SUBSTANTIALLY EQUIVALENT
1
CENTURION MEDICAL PRODUCTS
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
EMBRACE MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
FILMEC CO. LTD.
SUBSTANTIALLY EQUIVALENT
2
FILMECC CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
FILMECC CO., LTD
SUBSTANTIALLY EQUIVALENT
2
FILMECC CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
FLAT MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
FMD CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HERAEUS MEDICAL COMPONENTS, LLC
SUBSTANTIALLY EQUIVALENT
1
LAKE REGION MEDICAL
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC VASCULAR
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEM, INC.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
2
OPSENS INC.
SUBSTANTIALLY EQUIVALENT
2
PHENOX LIMITED
SUBSTANTIALLY EQUIVALENT
1
SCIENTIA CARDIO ACCESS LLC
SUBSTANTIALLY EQUIVALENT
1
SCIENTIA VASCULAR LLC
SUBSTANTIALLY EQUIVALENT
2
SEVEN SONS LTD.
SUBSTANTIALLY EQUIVALENT
1
SPARTAN MICRO, INC.
SUBSTANTIALLY EQUIVALENT
1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
SUZHOU INNOMED MEDICAL DEVICE CO.,LTD
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS LLC
SUBSTANTIALLY EQUIVALENT
2
VESATEK, LLC
SUBSTANTIALLY EQUIVALENT
1
VOLCANO CORPORATION
SUBSTANTIALLY EQUIVALENT
2
WILLIAM COOK EUROPE APS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1677
1677
2020
1536
2024
2021
1712
3054
2022
1647
1647
2023
2069
2069
2024
376
376
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
1447
2423
Difficult to Remove
1136
1136
Detachment of Device or Device Component
1026
1026
Break
923
923
Fracture
887
887
Difficult to Advance
804
804
Peeled/Delaminated
713
713
Adverse Event Without Identified Device or Use Problem
701
823
Entrapment of Device
502
1478
Failure to Advance
434
434
Deformation Due to Compressive Stress
360
360
Material Deformation
351
351
Unraveled Material
322
322
Stretched
314
314
Physical Resistance/Sticking
300
300
Material Integrity Problem
292
292
Material Split, Cut or Torn
246
246
Improper or Incorrect Procedure or Method
226
226
Insufficient Information
217
217
Product Quality Problem
111
111
Material Twisted/Bent
109
109
Positioning Problem
97
97
Material Frayed
85
85
Device Damaged by Another Device
80
80
Off-Label Use
77
77
Material Fragmentation
62
62
Flaked
55
55
Contamination /Decontamination Problem
55
55
Material Protrusion/Extrusion
54
54
Difficult to Insert
49
49
Material Too Soft/Flexible
46
46
Fluid/Blood Leak
43
43
Use of Device Problem
42
42
Unsealed Device Packaging
39
39
Activation, Positioning or Separation Problem
35
35
Defective Device
34
34
Device Contaminated During Manufacture or Shipping
34
34
Device Dislodged or Dislocated
28
28
Patient Device Interaction Problem
26
26
Device-Device Incompatibility
23
23
Device Contamination with Chemical or Other Material
23
23
Material Too Rigid or Stiff
22
22
Leak/Splash
20
20
Mechanical Jam
20
20
Communication or Transmission Problem
19
19
Device Damaged Prior to Use
19
19
Delivered as Unsterile Product
18
18
Difficult or Delayed Positioning
18
18
Device Markings/Labelling Problem
18
18
Appropriate Term/Code Not Available
18
18
Material Puncture/Hole
15
15
Crack
14
14
No Apparent Adverse Event
14
14
Sharp Edges
14
136
Malposition of Device
14
14
Obstruction of Flow
14
14
Mechanical Problem
13
13
Retraction Problem
13
13
Material Perforation
12
12
Device Handling Problem
11
11
Connection Problem
10
10
Incorrect, Inadequate or Imprecise Result or Readings
10
10
Tear, Rip or Hole in Device Packaging
9
9
Output Problem
9
9
Component Misassembled
8
8
Infusion or Flow Problem
7
7
Packaging Problem
7
7
Pressure Problem
7
7
Separation Failure
7
7
Defective Component
7
7
Solder Joint Fracture
6
6
Inadequacy of Device Shape and/or Size
6
6
Loose or Intermittent Connection
6
6
Gas Output Problem
6
6
Device Displays Incorrect Message
6
6
Device Misassembled During Manufacturing /Shipping
6
6
Separation Problem
6
6
Difficult or Delayed Activation
5
5
Patient-Device Incompatibility
5
5
Unintended Movement
5
5
Incorrect Measurement
5
5
Migration or Expulsion of Device
5
5
Contamination
5
5
Accessory Incompatible
5
5
Material Rupture
5
5
Component Missing
4
4
Overheating of Device
4
4
Device Difficult to Setup or Prepare
4
4
Disconnection
4
4
Degraded
4
4
Positioning Failure
4
4
Scratched Material
4
4
Therapeutic or Diagnostic Output Failure
4
4
Inadequate Lubrication
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Migration
3
3
Device Sensing Problem
3
3
Human-Device Interface Problem
3
3
Display or Visual Feedback Problem
3
3
Unable to Obtain Readings
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3556
4654
No Consequences Or Impact To Patient
1458
1458
Foreign Body In Patient
1094
1094
Device Embedded In Tissue or Plaque
593
593
Vascular Dissection
434
556
Insufficient Information
376
376
No Known Impact Or Consequence To Patient
354
842
Perforation of Vessels
272
394
Perforation
175
175
No Patient Involvement
169
169
Low Blood Pressure/ Hypotension
129
129
Pericardial Effusion
129
129
Cardiac Perforation
127
127
Cardiac Tamponade
124
124
Vessel Or Plaque, Device Embedded In
105
105
No Code Available
97
97
Myocardial Infarction
94
94
Hemorrhage/Bleeding
91
91
Death
81
81
Obstruction/Occlusion
58
58
Intimal Dissection
47
47
Cardiac Arrest
45
45
Hematoma
45
45
Stroke/CVA
44
44
Pain
41
41
Embolism
38
38
No Information
37
37
Hemoptysis
36
36
Embolism/Embolus
30
30
Thrombosis/Thrombus
30
30
Blood Loss
29
29
Vasoconstriction
27
27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
27
27
Occlusion
26
26
Intracranial Hemorrhage
25
25
Rupture
25
25
Patient Problem/Medical Problem
22
22
Laceration(s)
20
20
Arrhythmia
19
19
Bradycardia
18
18
Unspecified Tissue Injury
17
17
Unspecified Infection
16
16
High Blood Pressure/ Hypertension
15
15
Injury
15
15
Tachycardia
14
14
Calcium Deposits/Calcification
14
14
Extravasation
13
13
Chest Pain
13
13
Thrombosis
13
13
Thrombus
12
12
Foreign Body Embolism
12
12
Stenosis
11
11
Ventricular Fibrillation
10
10
Embolus
10
10
Angina
9
9
Ischemia
9
9
Inflammation
8
8
Failure of Implant
8
8
Atrial Fibrillation
8
8
Transient Ischemic Attack
8
8
Needle Stick/Puncture
8
8
Cardiogenic Shock
8
8
Discomfort
7
7
Complete Heart Block
7
7
Swelling/ Edema
7
7
Pseudoaneurysm
6
6
Diminished Pulse Pressure
6
6
Great Vessel Perforation
6
6
Aneurysm
6
6
Dyspnea
5
5
Paralysis
5
5
Muscle Weakness
5
5
Respiratory Failure
5
5
Cramp(s) /Muscle Spasm(s)
5
5
Mitral Valve Insufficiency/ Regurgitation
5
5
Heart Block
4
4
Aortic Valve Insufficiency/ Regurgitation
4
4
Hemorrhagic Stroke
4
4
Unspecified Nervous System Problem
4
4
Ruptured Aneurysm
4
4
Cognitive Changes
4
4
Dysphasia
4
4
Pleural Effusion
4
4
Hypersensitivity/Allergic reaction
4
4
Non specific EKG/ECG Changes
4
4
Bone Fracture(s)
4
4
Headache
3
3
Anaphylactic Shock
3
3
Syncope
3
3
Hypoxia
3
3
Paresis
3
3
Pulmonary Edema
3
3
Mitral Regurgitation
3
3
Brain Injury
3
3
Visual Impairment
3
3
Thromboembolism
3
3
Numbness
3
3
Coma
3
3
Arteriosclerosis/ Atherosclerosis
3
3
Speech Disorder
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Anewmed Corporation
II
Oct-31-2019
2
Argon Medical Devices, Inc
I
May-07-2020
3
Arrow International Inc
II
Jan-23-2020
4
Boston Scientific Corporation
II
Feb-20-2019
5
Cook Inc.
I
Nov-03-2020
6
Cook Incorporated
II
Sep-28-2022
7
Cook Incorporated
II
Sep-09-2022
8
Stryker Neurovascular
II
Oct-29-2019
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