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TPLC
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Device
catheter, flow directed
Product Code
DYG
Regulation Number
870.1240
Device Class
2
Premarket Reviews
Manufacturer
Decision
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCESS LLC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
144
144
2020
104
104
2021
97
97
2022
130
130
2023
227
227
2024
50
50
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
112
112
Pacing Problem
67
67
Inflation Problem
61
61
Deflation Problem
52
52
Incorrect, Inadequate or Imprecise Result or Readings
50
50
Incorrect Measurement
45
45
Leak/Splash
42
42
Adverse Event Without Identified Device or Use Problem
39
39
Appropriate Term/Code Not Available
30
30
Failure to Capture
27
27
Difficult to Advance
27
27
Material Separation
21
21
Burst Container or Vessel
21
21
Material Split, Cut or Torn
21
21
Break
20
20
Detachment of Device or Device Component
20
20
Physical Resistance/Sticking
17
17
Difficult to Remove
15
15
No Pacing
13
13
Material Puncture/Hole
12
12
Fluid/Blood Leak
12
12
Material Deformation
10
10
Failure to Deflate
9
9
No Device Output
9
9
Defective Device
8
8
Unable to Obtain Readings
8
8
Material Integrity Problem
8
8
Component Missing
7
7
Difficult or Delayed Positioning
7
7
Obstruction of Flow
6
6
Material Twisted/Bent
6
6
Difficult to Insert
6
6
Insufficient Flow or Under Infusion
4
4
Entrapment of Device
4
4
Material Fragmentation
4
4
Inaccurate Information
4
4
Defective Component
4
4
Failure to Advance
4
4
Therapeutic or Diagnostic Output Failure
4
4
Activation, Positioning or Separation Problem
4
4
Use of Device Problem
4
4
Connection Problem
4
4
High Test Results
3
3
Device Displays Incorrect Message
3
3
Product Quality Problem
3
3
Contamination
3
3
Gas/Air Leak
3
3
Patient-Device Incompatibility
3
3
Crack
3
3
Output Problem
3
3
Insufficient Information
2
2
Separation Problem
2
2
Disconnection
2
2
Malposition of Device
2
2
Device Contamination with Chemical or Other Material
2
2
Pacing Inadequately
2
2
Tear, Rip or Hole in Device Packaging
2
2
Capturing Problem
2
2
Difficult to Flush
2
2
Device Dislodged or Dislocated
2
2
Failure to Calibrate
1
1
Structural Problem
1
1
Deformation Due to Compressive Stress
1
1
Shipping Damage or Problem
1
1
Degraded
1
1
Particulates
1
1
Signal Artifact/Noise
1
1
Unintended Deflation
1
1
Retraction Problem
1
1
Increase in Pressure
1
1
Coagulation in Device or Device Ingredient
1
1
Contamination /Decontamination Problem
1
1
Delivered as Unsterile Product
1
1
Activation Failure
1
1
Improper or Incorrect Procedure or Method
1
1
Device Contamination with Body Fluid
1
1
Device Ingredient or Reagent Problem
1
1
Unexpected Therapeutic Results
1
1
Migration or Expulsion of Device
1
1
Failure to Sense
1
1
Unintended Movement
1
1
Inadequacy of Device Shape and/or Size
1
1
Pressure Problem
1
1
Low Test Results
1
1
Complete Blockage
1
1
Pacing Intermittently
1
1
Unclear Information
1
1
Material Protrusion/Extrusion
1
1
Excess Flow or Over-Infusion
1
1
Off-Label Use
1
1
Device Markings/Labelling Problem
1
1
Device Alarm System
1
1
Difficult or Delayed Activation
1
1
Temperature Problem
1
1
Calibration Problem
1
1
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
400
400
No Consequences Or Impact To Patient
146
146
No Known Impact Or Consequence To Patient
114
114
Insufficient Information
54
54
Hemorrhage/Bleeding
12
12
Vascular Dissection
11
11
No Patient Involvement
10
10
Arrhythmia
9
9
No Code Available
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
No Information
6
6
Great Vessel Perforation
6
6
Cardiac Tamponade
6
6
Low Blood Pressure/ Hypotension
6
6
Cardiac Perforation
5
5
Needle Stick/Puncture
4
4
Device Embedded In Tissue or Plaque
4
4
Hypersensitivity/Allergic reaction
4
4
High Blood Pressure/ Hypertension
3
3
Pain
3
3
Anaphylactic Shock
3
3
Bradycardia
3
3
Cardiac Arrest
3
3
Chest Pain
3
3
Dyspnea
3
3
Foreign Body In Patient
3
3
Low Oxygen Saturation
2
2
Complaint, Ill-Defined
2
2
Rupture
2
2
Anaphylactoid
2
2
Perforation of Vessels
2
2
Unspecified Vascular Problem
2
2
Swelling/ Edema
2
2
Extravasation
2
2
Death
2
2
Atrial Fibrillation
2
2
Perforation
2
2
Aortic Valve Stenosis
2
2
Hemoptysis
2
2
Failure of Implant
2
2
Unspecified Infection
2
2
Myocardial Infarction
1
1
Pneumothorax
1
1
Sepsis
1
1
Septic Shock
1
1
Therapeutic Effects, Unexpected
1
1
Thrombus
1
1
Tissue Damage
1
1
Atrial Flutter
1
1
Exposure to Body Fluids
1
1
Anemia
1
1
Pulmonary Embolism
1
1
Air Embolism
1
1
Cardiopulmonary Arrest
1
1
Fever
1
1
Edema
1
1
Ectopic Heartbeat
1
1
Tingling
1
1
Injury
1
1
Reaction
1
1
Physical Entrapment
1
1
Blood Loss
1
1
Pseudoaneurysm
1
1
Complete Heart Block
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Dec-19-2019
2
Edwards Lifesciences, LLC
II
Apr-12-2023
3
Edwards Lifesciences, LLC
I
Jan-31-2019
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