Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
catheter, septostomy
Product Code
DXF
Regulation Number
870.5175
Device Class
2
Premarket Reviews
Manufacturer
Decision
ATRAVERSE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
BAYLIS MEDICAL COMPANY INC.
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
CROSS VASCULAR INC.
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
NUMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
21
21
2016
13
13
2017
13
13
2018
36
36
2019
24
24
2020
55
55
2021
39
39
2022
70
70
2023
288
288
2024
89
89
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
369
369
Failure to Advance
57
57
Difficult to Advance
47
47
Positioning Problem
38
38
Burst Container or Vessel
23
23
Material Integrity Problem
22
22
Display or Visual Feedback Problem
20
20
Material Deformation
18
18
Insufficient Information
17
17
Detachment of Device or Device Component
15
15
Device-Device Incompatibility
12
12
Deflation Problem
9
9
Use of Device Problem
9
9
Material Rupture
8
8
Physical Resistance/Sticking
8
8
Break
6
6
Material Frayed
5
5
Leak/Splash
5
5
Defective Device
5
5
Device Displays Incorrect Message
5
5
Packaging Problem
5
5
Device Dislodged or Dislocated
4
4
Difficult to Remove
4
4
Thermal Decomposition of Device
4
4
Material Separation
3
3
Peeled/Delaminated
3
3
Improper or Incorrect Procedure or Method
3
3
Obstruction of Flow
3
3
Deformation Due to Compressive Stress
3
3
Device Markings/Labelling Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Unintended Movement
2
2
Mechanical Problem
2
2
Material Puncture/Hole
2
2
Detachment Of Device Component
2
2
Contamination
2
2
Failure to Deliver Energy
2
2
Entrapment of Device
2
2
Difficult to Insert
2
2
High impedance
2
2
Difficult or Delayed Positioning
2
2
Positioning Failure
2
2
Inflation Problem
1
1
Partial Blockage
1
1
Loose or Intermittent Connection
1
1
Fracture
1
1
Migration or Expulsion of Device
1
1
Unsealed Device Packaging
1
1
Off-Label Use
1
1
Device Damaged Prior to Use
1
1
Component Missing
1
1
Tear, Rip or Hole in Device Packaging
1
1
Failure to Fire
1
1
Patient-Device Incompatibility
1
1
No Apparent Adverse Event
1
1
Appropriate Term/Code Not Available
1
1
Electromagnetic Compatibility Problem
1
1
Improper Flow or Infusion
1
1
Output below Specifications
1
1
Device Operates Differently Than Expected
1
1
Communication or Transmission Problem
1
1
Activation, Positioning or Separation Problem
1
1
Difficult to Open or Close
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pericardial Effusion
252
252
No Clinical Signs, Symptoms or Conditions
127
127
Cardiac Tamponade
124
124
Low Blood Pressure/ Hypotension
90
90
Cardiac Perforation
55
55
Thrombosis/Thrombus
39
39
No Consequences Or Impact To Patient
38
38
Perforation
34
34
Hematoma
25
25
Perforation of Vessels
25
25
Hemorrhage/Bleeding
19
19
No Known Impact Or Consequence To Patient
17
17
Cardiac Arrest
16
16
Stroke/CVA
13
13
Air Embolism
10
10
Arrhythmia
9
9
Death
8
8
Pseudoaneurysm
7
7
Foreign Body In Patient
6
6
Asystole
6
6
Tachycardia
6
6
Non specific EKG/ECG Changes
6
6
Dyspnea
5
5
Bradycardia
5
5
Chest Pain
5
5
Thrombus
5
5
Transient Ischemic Attack
5
5
Insufficient Information
5
5
Respiratory Arrest
4
4
Ventricular Fibrillation
4
4
Heart Block
4
4
Embolism/Embolus
4
4
Fistula
4
4
Hemothorax
4
4
High Blood Pressure/ Hypertension
4
4
Hypoxia
3
3
Burn(s)
3
3
Thromboembolism
3
3
Ventricular Tachycardia
3
3
Pain
2
2
Shock
2
2
Electric Shock
2
2
Stenosis
2
2
Diaphoresis
2
2
Needle Stick/Puncture
2
2
Vascular Dissection
2
2
Device Embedded In Tissue or Plaque
2
2
No Code Available
2
2
Pericarditis
2
2
Atrial Fibrillation
2
2
Pulmonary Embolism
2
2
Hemoptysis
2
2
Embolism
2
2
Ischemia
2
2
Pleural Effusion
2
2
Intracranial Hemorrhage
2
2
Swelling/ Edema
2
2
Unspecified Respiratory Problem
1
1
Unspecified Tissue Injury
1
1
Unspecified Vascular Problem
1
1
Hypersensitivity/Allergic reaction
1
1
Hypopyon
1
1
Hypothermia
1
1
Pneumothorax
1
1
Pulmonary Valve Stenosis
1
1
Myocardial Infarction
1
1
Nerve Damage
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Infarction, Cerebral
1
1
Cough
1
1
Ischemia Stroke
1
1
No Information
1
1
Diminished Pulse Pressure
1
1
Complete Heart Block
1
1
Respiratory Failure
1
1
Low Cardiac Output
1
1
Hematuria
1
1
Rupture
1
1
Vomiting
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baylis Medical Corp *
II
Nov-10-2016
2
Edwards Lifesciences, LLC
I
Apr-25-2019
3
Medtronic Vascular
I
Oct-16-2020
-
-