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TPLC
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show TPLC since
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2024
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Device
stylet, catheter
Product Code
DRB
Regulation Number
870.1380
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
SUBSTANTIALLY EQUIVALENT
1
BIOTRONIK, INC
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
GALT MEDICAL CORP.
SUBSTANTIALLY EQUIVALENT
1
SPECTRANETICS, INC.
SUBSTANTIALLY EQUIVALENT
1
ST. JUDE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
67
67
2015
66
66
2016
55
55
2017
63
63
2018
40
40
2019
82
82
2020
92
92
2021
97
3635
2022
94
94
2023
82
82
2024
85
85
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
435
2265
Break
104
958
Mechanical Problem
53
785
Insufficient Information
38
38
Difficult to Remove
33
33
Device Operates Differently Than Expected
28
28
Material Separation
18
18
Failure to Advance
12
12
Device Inoperable
10
10
Retraction Problem
10
10
Detachment Of Device Component
9
9
Difficult to Advance
8
8
Appropriate Term/Code Not Available
7
7
Fracture
6
6
Detachment of Device or Device Component
6
6
Activation, Positioning or Separation Problem
6
6
Sticking
5
5
Positioning Problem
5
5
Device Expiration Issue
5
5
Device Dislodged or Dislocated
4
4
Entrapment of Device
4
4
Human-Device Interface Problem
4
4
Occlusion Within Device
4
4
Material Integrity Problem
4
4
Mechanical Jam
3
125
Physical Resistance
3
3
Difficult to Insert
3
3
Shelf Life Exceeded
3
3
Malposition of Device
3
3
Device Markings/Labelling Problem
3
3
Use of Device Problem
3
3
Contamination
3
3
Calcified
2
2
Product Quality Problem
2
2
Material Perforation
2
2
Material Deformation
2
2
Material Distortion
2
2
Material Too Rigid or Stiff
2
2
Patient-Device Incompatibility
2
2
Physical Resistance/Sticking
2
2
High impedance
2
2
Cut In Material
2
2
Fitting Problem
2
2
Device Slipped
2
2
Pressure Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Therapeutic or Diagnostic Output Failure
1
1
Patient Device Interaction Problem
1
1
Scratched Material
1
1
Filling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Device Embedded In Tissue or Plaque
239
1825
Cardiac Perforation
210
1064
Iatrogenic Source
188
432
Pericardial Effusion
147
391
Low Blood Pressure/ Hypotension
115
115
No Known Impact Or Consequence To Patient
49
49
Death
42
42
Unspecified Infection
40
40
No Clinical Signs, Symptoms or Conditions
37
1135
Atrial Perforation
36
36
Perforation of Vessels
35
35
Injury
33
33
Cardiac Tamponade
28
28
Great Vessel Perforation
25
25
Laceration(s)
21
21
Perforation
21
21
No Consequences Or Impact To Patient
19
19
Foreign Body In Patient
18
18
Tissue Damage
13
13
No Code Available
12
12
Hemorrhage/Bleeding
11
11
Calcium Deposits/Calcification
9
9
Scarring
4
4
Blood Loss
4
4
Excessive Tear Production
4
4
Pleural Effusion
4
4
No Information
4
4
Complaint, Ill-Defined
3
3
Bacterial Infection
3
3
Pulmonary Embolism
2
2
Thrombus
2
2
Fibrosis
2
2
Sepsis
2
2
Endocarditis
2
2
Hematoma
2
2
Cardiac Arrest
2
2
Exsanguination
2
2
Pain
1
1
Bradycardia
1
1
Scar Tissue
1
1
Vascular System (Circulation), Impaired
1
1
Occlusion
1
1
Ventricular Fibrillation
1
1
Tricuspid Valve Insufficiency/ Regurgitation
1
1
Discharge
1
1
Tricuspid Regurgitation
1
1
Dry Eye(s)
1
1
Adhesion(s)
1
1
Staphylococcus Aureus
1
1
Diminished Pulse Pressure
1
1
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