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TPLC
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Device
catheter, intravascular, diagnostic
Regulation Description
Diagnostic intravascular catheter.
Product Code
DQO
Regulation Number
870.1200
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ACCURATE MEDICAL THERAPEUTICS
SUBSTANTIALLY EQUIVALENT
1
ACCURATE MEDICAL THERAPEUTICS LTD
SUBSTANTIALLY EQUIVALENT
1
ACCURATE MEDICAL THERAPEUTICS LTD.
SUBSTANTIALLY EQUIVALENT
1
CORDIS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
CORDIS US CORP.
SUBSTANTIALLY EQUIVALENT
1
EMBOLX, INC.
SUBSTANTIALLY EQUIVALENT
1
GENTUITY, LLC
SUBSTANTIALLY EQUIVALENT
2
IMPERATIVE CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
PFM MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
PHENOX LTD
SUBSTANTIALLY EQUIVALENT
2
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
TERUMO CLINICAL SUPPLY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
312
312
2021
337
337
2022
379
379
2023
391
391
2024
512
512
2025
35
35
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
522
522
Fracture
497
497
Detachment of Device or Device Component
264
264
Difficult to Remove
158
158
Adverse Event Without Identified Device or Use Problem
155
155
Break
129
129
Crack
94
94
Difficult to Advance
61
61
Fluid/Blood Leak
52
52
Material Puncture/Hole
49
49
Material Split, Cut or Torn
48
48
Device Contamination with Chemical or Other Material
41
41
Material Deformation
35
35
Leak/Splash
31
31
Failure to Advance
30
30
Entrapment of Device
28
28
Device Contaminated During Manufacture or Shipping
28
28
Physical Resistance/Sticking
27
27
Material Twisted/Bent
26
26
Deformation Due to Compressive Stress
24
24
Degraded
23
23
Tear, Rip or Hole in Device Packaging
22
22
Communication or Transmission Problem
20
20
Difficult to Insert
19
19
Material Fragmentation
18
18
Material Rupture
18
18
Incorrect, Inadequate or Imprecise Result or Readings
17
17
Gas/Air Leak
16
16
No Display/Image
16
16
Material Integrity Problem
15
15
Unable to Obtain Readings
15
15
Peeled/Delaminated
15
15
Material Frayed
15
15
Device-Device Incompatibility
14
14
Improper or Incorrect Procedure or Method
13
13
Separation Problem
12
12
Poor Quality Image
12
12
Stretched
12
12
Use of Device Problem
10
10
Obstruction of Flow
10
10
Device Damaged by Another Device
9
9
Disconnection
9
9
Burst Container or Vessel
8
8
Structural Problem
8
8
Unraveled Material
8
8
Defective Device
8
8
Contamination
7
7
Contamination /Decontamination Problem
7
7
Material Protrusion/Extrusion
7
7
Deflation Problem
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1236
1236
Foreign Body In Patient
222
222
No Consequences Or Impact To Patient
115
115
Vascular Dissection
77
77
Insufficient Information
59
59
No Known Impact Or Consequence To Patient
39
39
No Patient Involvement
38
38
Thrombosis/Thrombus
30
30
Device Embedded In Tissue or Plaque
29
29
Stroke/CVA
23
23
No Code Available
20
20
Obstruction/Occlusion
19
19
Perforation of Vessels
17
17
Cardiac Arrest
15
15
Chest Pain
13
13
Vasoconstriction
12
12
Hemorrhage/Bleeding
11
11
Non specific EKG/ECG Changes
9
9
Speech Disorder
8
8
Rupture
8
8
Low Blood Pressure/ Hypotension
8
8
Air Embolism
7
7
Ischemia
7
7
Ventricular Fibrillation
7
7
Pericardial Effusion
7
7
Hematoma
7
7
Cardiac Perforation
6
6
Dyspnea
6
6
Death
6
6
Intracranial Hemorrhage
5
5
Failure of Implant
5
5
Cardiac Tamponade
5
5
Paralysis
5
5
Muscle Weakness
5
5
Cardiogenic Shock
5
5
Occlusion
5
5
Hypersensitivity/Allergic reaction
4
4
Thromboembolism
4
4
Renal Failure
4
4
Paresis
4
4
Ischemia Stroke
4
4
Embolism/Embolus
4
4
Arrhythmia
4
4
Angina
4
4
Pain
4
4
Myocardial Infarction
4
4
Tachycardia
3
3
Brain Injury
3
3
Muscle Spasm(s)
3
3
Unspecified Tissue Injury
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Vascular
I
May-19-2022
2
Angiodynamics, Inc.
II
Jul-31-2024
3
Boston Scientific Corporation
I
May-10-2024
4
Boston Scientific Corporation
I
Mar-25-2020
5
Cordis Corporation
I
Sep-15-2021
6
Cordis US Corp
I
Nov-09-2023
7
Cordis US Corp
II
Dec-16-2022
8
Stryker Neurovascular
II
May-28-2024
9
Stryker Neurovascular
II
Jul-15-2022
10
Stryker, Inc.
II
Feb-14-2024
11
Vascular Solutions, Inc.
I
Oct-20-2020
12
Vascular Solutions, Inc.
I
Apr-27-2020
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