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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
GALT MEDICAL CORP.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
82
82
2020
92
92
2021
97
3635
2022
94
94
2023
82
82
2024
48
48
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
352
2182
Break
64
918
Mechanical Problem
48
780
Material Separation
14
14
Activation, Positioning or Separation Problem
6
6
Detachment of Device or Device Component
4
4
Use of Device Problem
3
3
Product Quality Problem
2
2
Difficult to Remove
2
2
Physical Resistance/Sticking
2
2
Material Integrity Problem
2
2
Mechanical Jam
2
124
Device Damaged by Another Device
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Deformation
1
1
Crack
1
1
Deformation Due to Compressive Stress
1
1
Device Slipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Device Embedded In Tissue or Plaque
197
1783
Cardiac Perforation
175
1029
Iatrogenic Source
165
409
Pericardial Effusion
97
341
No Clinical Signs, Symptoms or Conditions
37
1135
Atrial Perforation
32
32
Perforation of Vessels
20
20
Great Vessel Perforation
20
20
Death
16
16
No Known Impact Or Consequence To Patient
13
13
Cardiac Tamponade
11
11
No Consequences Or Impact To Patient
8
8
Low Blood Pressure/ Hypotension
6
6
Pleural Effusion
3
3
No Code Available
3
3
Tricuspid Valve Insufficiency/ Regurgitation
1
1
Thrombus
1
1
Tricuspid Regurgitation
1
1
Laceration(s)
1
1
Internal Organ Perforation
1
1
Pain
1
1
Perforation
1
1
Exsanguination
1
1
Hemorrhage/Bleeding
1
1
Pulmonary Embolism
1
1
Atrial Fibrillation
1
1
Bradycardia
1
1
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