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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
CROSS VASCULAR INC.
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
NUMED, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K211910
Z-6 Atrioseptostomy Catheter
MDR Year
MDR Reports
MDR Events
2019
24
24
2020
55
55
2021
39
39
2022
70
70
2023
288
288
2024
67
67
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
305
305
Failure to Advance
54
54
Difficult to Advance
42
42
Positioning Problem
37
37
Material Integrity Problem
21
21
Display or Visual Feedback Problem
19
19
Material Deformation
16
16
Insufficient Information
15
15
Burst Container or Vessel
15
15
Detachment of Device or Device Component
14
14
Device-Device Incompatibility
11
11
Use of Device Problem
9
9
Physical Resistance/Sticking
7
7
Defective Device
5
5
Break
5
5
Thermal Decomposition of Device
4
4
Deflation Problem
4
4
Material Frayed
4
4
Leak/Splash
4
4
Device Displays Incorrect Message
4
4
Difficult to Remove
4
4
Device Dislodged or Dislocated
4
4
Material Rupture
3
3
Deformation Due to Compressive Stress
3
3
Material Separation
2
2
Material Puncture/Hole
2
2
Device Markings/Labelling Problem
2
2
High impedance
2
2
Difficult to Insert
2
2
Difficult or Delayed Positioning
2
2
Positioning Failure
2
2
Failure to Deliver Energy
2
2
Device Contaminated During Manufacture or Shipping
2
2
Packaging Problem
2
2
Unintended Movement
2
2
No Apparent Adverse Event
1
1
Appropriate Term/Code Not Available
1
1
Output below Specifications
1
1
Electromagnetic Compatibility Problem
1
1
Improper Flow or Infusion
1
1
Entrapment of Device
1
1
Fracture
1
1
Contamination
1
1
Mechanical Problem
1
1
Migration or Expulsion of Device
1
1
Unsealed Device Packaging
1
1
Off-Label Use
1
1
Communication or Transmission Problem
1
1
Activation, Positioning or Separation Problem
1
1
Failure to Fire
1
1
Patient-Device Incompatibility
1
1
Improper or Incorrect Procedure or Method
1
1
Component Missing
1
1
Obstruction of Flow
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pericardial Effusion
214
214
No Clinical Signs, Symptoms or Conditions
117
117
Cardiac Tamponade
110
110
Low Blood Pressure/ Hypotension
84
84
Cardiac Perforation
46
46
Thrombosis/Thrombus
39
39
Perforation
32
32
Perforation of Vessels
25
25
Hematoma
22
22
Hemorrhage/Bleeding
16
16
Cardiac Arrest
16
16
No Consequences Or Impact To Patient
15
15
Air Embolism
10
10
Arrhythmia
9
9
Stroke/CVA
9
9
Death
7
7
Non specific EKG/ECG Changes
6
6
Asystole
6
6
Foreign Body In Patient
5
5
Tachycardia
5
5
Chest Pain
5
5
Dyspnea
5
5
Bradycardia
5
5
Insufficient Information
5
5
Fistula
4
4
Hemothorax
4
4
High Blood Pressure/ Hypertension
4
4
Pseudoaneurysm
4
4
Ventricular Fibrillation
4
4
No Known Impact Or Consequence To Patient
4
4
Heart Block
4
4
Respiratory Arrest
4
4
Embolism/Embolus
4
4
Transient Ischemic Attack
3
3
Hypoxia
3
3
Burn(s)
3
3
Atrial Fibrillation
2
2
Embolism
2
2
Intracranial Hemorrhage
2
2
Hemoptysis
2
2
Shock
2
2
Pleural Effusion
2
2
Diaphoresis
2
2
Thromboembolism
2
2
Electric Shock
2
2
Swelling/ Edema
2
2
Pericarditis
2
2
Vascular Dissection
2
2
Device Embedded In Tissue or Plaque
2
2
No Code Available
1
1
Unspecified Vascular Problem
1
1
Ischemia Stroke
1
1
Cough
1
1
Unspecified Respiratory Problem
1
1
Rupture
1
1
Diminished Pulse Pressure
1
1
Complete Heart Block
1
1
Needle Stick/Puncture
1
1
Respiratory Failure
1
1
Low Cardiac Output
1
1
Vomiting
1
1
Pneumothorax
1
1
Pulmonary Valve Stenosis
1
1
Hypothermia
1
1
Ischemia
1
1
Myocardial Infarction
1
1
Nerve Damage
1
1
Pain
1
1
Hypopyon
1
1
Hypersensitivity/Allergic reaction
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Infarction, Cerebral
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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