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TPLC
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show TPLC since
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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
4
ASAHI INTECC CO., LTD.
SUBSTANTIALLY EQUIVALENT
11
BAYLIS MEDICAL COMPANY INC.
SUBSTANTIALLY EQUIVALENT
2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
BIOMERICS NLE
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC INC.
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
9
EMBRACE MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
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 CORE VALVE, LLC.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEM, INC.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
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
3
SEVEN SONS LTD.
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., 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
2
VASCULAR SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS LLC
SUBSTANTIALLY EQUIVALENT
2
VASCULAR SOLUTIONS, INC
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
VESATEK, LLC
SUBSTANTIALLY EQUIVALENT
1
VOLCANO CORPORATION
SUBSTANTIALLY EQUIVALENT
2
WILLIAM COOK EUROPE APS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1736
1736
2019
1677
1677
2020
1536
2024
2021
1712
3054
2022
1647
1647
2023
1407
1407
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
1514
2490
Difficult to Remove
1254
1254
Break
1113
1113
Detachment of Device or Device Component
1086
1086
Fracture
891
891
Peeled/Delaminated
781
781
Adverse Event Without Identified Device or Use Problem
741
863
Difficult to Advance
728
728
Entrapment of Device
584
1560
Failure to Advance
469
469
Stretched
385
385
Material Deformation
379
379
Unraveled Material
335
335
Deformation Due to Compressive Stress
320
320
Material Integrity Problem
316
316
Improper or Incorrect Procedure or Method
267
267
Physical Resistance/Sticking
260
260
Material Split, Cut or Torn
215
215
Insufficient Information
211
211
Detachment Of Device Component
197
197
Material Twisted/Bent
119
119
Product Quality Problem
115
115
Material Frayed
103
103
Positioning Problem
101
101
Device Damaged by Another Device
95
95
Material Fragmentation
85
85
Off-Label Use
84
84
Material Protrusion/Extrusion
80
80
Flaked
74
74
Fluid/Blood Leak
54
54
Contamination /Decontamination Problem
53
53
Difficult to Insert
52
52
Material Too Soft/Flexible
48
48
Unsealed Device Packaging
40
40
Difficult To Position
40
40
Device Dislodged or Dislocated
40
40
Use of Device Problem
38
38
Device Damaged Prior to Use
38
38
Defective Device
37
37
Device Contamination with Chemical or Other Material
37
37
Kinked
37
37
Activation, Positioning or Separation Problem
36
36
Appropriate Term/Code Not Available
29
29
Device Operates Differently Than Expected
26
26
Leak/Splash
24
24
Physical Resistance
22
22
Device-Device Incompatibility
21
21
Device Contaminated During Manufacture or Shipping
21
21
Patient Device Interaction Problem
21
21
Mechanical Jam
20
20
Device Markings/Labelling Problem
20
20
Bent
20
20
Difficult or Delayed Positioning
20
20
Delivered as Unsterile Product
20
20
Mechanical Problem
19
19
Crack
18
18
Communication or Transmission Problem
18
18
Retraction Problem
16
16
Material Too Rigid or Stiff
16
16
Malposition of Device
15
15
Obstruction of Flow
15
15
Material Perforation
14
14
Material Puncture/Hole
13
13
No Apparent Adverse Event
13
13
Torn Material
11
11
Sharp Edges
11
133
Connection Problem
11
11
Uncoiled
10
10
Device Displays Incorrect Message
10
10
Structural Problem
10
10
Incorrect, Inadequate or Imprecise Result or Readings
10
10
Device Handling Problem
10
10
Output Problem
9
9
Tear, Rip or Hole in Device Packaging
9
9
Delamination
9
9
Loose or Intermittent Connection
8
8
Packaging Problem
8
8
Scratched Material
7
7
Separation Problem
7
7
Migration or Expulsion of Device
7
7
Infusion or Flow Problem
7
7
Defective Component
7
7
Separation Failure
7
7
Patient-Device Incompatibility
7
7
Split
6
6
Component Missing
6
6
Inadequacy of Device Shape and/or Size
6
6
Gas Output Problem
6
6
Contamination
6
6
Degraded
5
5
Accessory Incompatible
5
5
Material Rupture
5
5
Solder Joint Fracture
5
5
Difficult or Delayed Activation
5
5
Component Misassembled
5
5
Physical Property Issue
5
5
Unintended Movement
5
5
Therapeutic or Diagnostic Output Failure
4
4
Inadequate Lubrication
4
4
Failure to Zero
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2906
4004
No Consequences Or Impact To Patient
2290
2290
Foreign Body In Patient
1032
1032
Device Embedded In Tissue or Plaque
770
770
No Known Impact Or Consequence To Patient
610
1098
Vascular Dissection
390
512
Insufficient Information
358
358
No Patient Involvement
283
283
Perforation of Vessels
237
359
Perforation
180
180
Vessel Or Plaque, Device Embedded In
157
157
Pericardial Effusion
138
138
No Code Available
134
134
Cardiac Perforation
132
132
Low Blood Pressure/ Hypotension
130
130
Cardiac Tamponade
120
120
Death
117
117
Hemorrhage/Bleeding
92
92
Intimal Dissection
68
68
Myocardial Infarction
58
58
No Information
56
56
Cardiac Arrest
45
45
Hematoma
43
43
Embolism
41
41
Pain
41
41
Obstruction/Occlusion
39
39
Stroke/CVA
39
39
Blood Loss
37
37
Patient Problem/Medical Problem
32
32
Occlusion
30
30
Rupture
30
30
Hemoptysis
29
29
Thrombosis/Thrombus
27
27
Embolism/Embolus
26
26
Intracranial Hemorrhage
26
26
Vasoconstriction
26
26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Laceration(s)
20
20
Arrhythmia
20
20
Bradycardia
19
19
Thrombosis
18
18
Angina
17
17
Unspecified Tissue Injury
17
17
Calcium Deposits/Calcification
16
16
Chest Pain
16
16
Injury
16
16
Cardiogenic Shock
15
15
Thrombus
15
15
Unspecified Infection
15
15
Extravasation
13
13
Tachycardia
12
12
Foreign Body Embolism
12
12
Stenosis
11
11
Ischemia
11
11
High Blood Pressure/ Hypertension
11
11
Embolus
10
10
Aneurysm
10
10
Ventricular Fibrillation
10
10
Atrial Fibrillation
9
9
Inflammation
8
8
Transient Ischemic Attack
8
8
Needle Stick/Puncture
7
7
Discomfort
7
7
Bone Fracture(s)
7
7
Dyspnea
7
7
Diminished Pulse Pressure
7
7
Complete Heart Block
7
7
Swelling/ Edema
6
6
Non specific EKG/ECG Changes
6
6
Hemorrhage, Subarachnoid
6
6
Failure of Implant
6
6
Pleural Effusion
6
6
Respiratory Failure
6
6
Tissue Damage
6
6
Paralysis
5
5
Muscle Weakness
5
5
Air Embolism
5
5
Syncope
5
5
Cramp(s) /Muscle Spasm(s)
5
5
Mitral Valve Insufficiency/ Regurgitation
5
5
Pseudoaneurysm
5
5
Heart Block
4
4
Hemorrhagic Stroke
4
4
Unspecified Nervous System Problem
4
4
Ruptured Aneurysm
4
4
Aortic Valve Insufficiency/ Regurgitation
4
4
Mitral Regurgitation
4
4
Pneumothorax
4
4
Hypoxia
4
4
Hypersensitivity/Allergic reaction
4
4
Headache
4
4
Paresis
4
4
Sepsis
4
4
Shock
4
4
Dysphasia
4
4
Great Vessel Perforation
4
4
Low Cardiac Output
4
4
Cognitive Changes
4
4
Loss Of Pulse
3
3
Numbness
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
Arrow International Inc
II
May-30-2018
5
Arrow International Inc
II
Apr-10-2018
6
Arrow International Inc
II
Apr-02-2018
7
Boston Scientific Corporation
II
Feb-20-2019
8
Cook Inc.
I
Nov-03-2020
9
Cook Inc.
II
Mar-09-2018
10
Cook Incorporated
II
Sep-28-2022
11
Cook Incorporated
II
Sep-09-2022
12
Stryker Neurovascular
II
Oct-29-2019
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