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TPLC
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Device
catheter, septostomy
Product Code
DXF
Regulation Number
870.5175
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
NUMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
36
36
2019
24
24
2020
55
55
2021
39
39
2022
70
70
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
160
160
Burst Container or Vessel
22
22
Insufficient Information
8
8
Deflation Problem
6
6
Detachment of Device or Device Component
5
5
Material Rupture
5
5
Break
4
4
Leak/Splash
4
4
Improper or Incorrect Procedure or Method
3
3
Material Separation
3
3
Deformation Due to Compressive Stress
3
3
Material Puncture/Hole
2
2
Packaging Problem
2
2
High impedance
2
2
Material Deformation
2
2
Failure to Fire
1
1
Device-Device Incompatibility
1
1
Failure to Deliver Energy
1
1
Fracture
1
1
Inflation Problem
1
1
Migration or Expulsion of Device
1
1
Off-Label Use
1
1
Loose or Intermittent Connection
1
1
Device Damaged Prior to Use
1
1
Device Displays Incorrect Message
1
1
Entrapment of Device
1
1
No Apparent Adverse Event
1
1
Difficult to Open or Close
1
1
Device Dislodged or Dislocated
1
1
Mechanical Problem
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pericardial Effusion
71
71
Cardiac Tamponade
47
47
No Consequences Or Impact To Patient
26
26
No Clinical Signs, Symptoms or Conditions
22
22
No Known Impact Or Consequence To Patient
12
12
Perforation
11
11
Thrombosis/Thrombus
8
8
Stroke/CVA
8
8
Death
7
7
Hematoma
6
6
Cardiac Perforation
6
6
Embolism/Embolus
4
4
Pseudoaneurysm
4
4
Foreign Body In Patient
4
4
Transient Ischemic Attack
3
3
Hemothorax
3
3
Perforation of Vessels
3
3
Insufficient Information
3
3
Pericarditis
2
2
Device Embedded In Tissue or Plaque
2
2
Embolism
2
2
Fistula
2
2
Tachycardia
2
2
Low Blood Pressure/ Hypotension
2
2
Hemorrhage/Bleeding
2
2
Heart Block
2
2
Thromboembolism
2
2
Hemoptysis
1
1
Infarction, Cerebral
1
1
Arrhythmia
1
1
Bradycardia
1
1
No Code Available
1
1
Complete Heart Block
1
1
Dyspnea
1
1
Cardiac Arrest
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Ischemia Stroke
1
1
Nerve Damage
1
1
Pneumothorax
1
1
Cough
1
1
Unspecified Vascular Problem
1
1
Pulmonary Valve Stenosis
1
1
Thrombus
1
1
Air Embolism
1
1
High Blood Pressure/ Hypertension
1
1
Vascular Dissection
1
1
Rupture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Edwards Lifesciences, LLC
I
Apr-25-2019
2
Medtronic Vascular
I
Oct-16-2020
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