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TPLC
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Device
catheter, cannula and tubing, vascular, cardiopulmonary bypass
Product Code
DWF
Regulation Number
870.4210
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANGIODYNAMICS, INC.
SUBSTANTIALLY EQUIVALENT
2
CARDIOGARD MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES LLC
SUBSTANTIALLY EQUIVALENT
2
KAPP SURGICAL INSTRUMENT, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
3
QURA S.R.L.
SUBSTANTIALLY EQUIVALENT
4
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
178
178
2020
142
142
2021
162
162
2022
276
276
2023
471
471
2024
45
45
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Deformation
165
165
Material Puncture/Hole
136
136
Fluid/Blood Leak
135
135
Mechanical Problem
132
132
Adverse Event Without Identified Device or Use Problem
130
130
Crack
125
125
Material Separation
89
89
Obstruction of Flow
51
51
Break
50
50
Detachment of Device or Device Component
46
46
Disconnection
41
41
Leak/Splash
38
38
Fracture
36
36
Material Twisted/Bent
24
24
Insufficient Information
24
24
Packaging Problem
22
22
Air/Gas in Device
20
20
Material Split, Cut or Torn
19
19
Loss of or Failure to Bond
18
18
Nonstandard Device
17
17
Migration
13
13
Gas/Air Leak
13
13
Misassembled During Installation
11
11
Difficult to Insert
11
11
Device Markings/Labelling Problem
10
10
Improper Flow or Infusion
9
9
Defective Component
9
9
Component Missing
8
8
Material Rupture
8
8
Increase in Pressure
7
7
Defective Device
7
7
Deformation Due to Compressive Stress
7
7
Device Contamination with Chemical or Other Material
7
7
Infusion or Flow Problem
6
6
No Flow
6
6
Material Integrity Problem
6
6
Ejection Problem
6
6
Loose or Intermittent Connection
6
6
Contamination
6
6
Coagulation in Device or Device Ingredient
6
6
Positioning Failure
5
5
Material Discolored
5
5
Unsealed Device Packaging
5
5
Restricted Flow rate
5
5
Malposition of Device
5
5
Improper or Incorrect Procedure or Method
5
5
Physical Resistance/Sticking
5
5
Appropriate Term/Code Not Available
5
5
Device Handling Problem
5
5
Positioning Problem
5
5
Therapeutic or Diagnostic Output Failure
4
4
Unintended Movement
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Difficult to Remove
4
4
Contamination /Decontamination Problem
4
4
Inflation Problem
4
4
Delivered as Unsterile Product
4
4
Partial Blockage
4
4
Backflow
3
3
Burst Container or Vessel
3
3
Complete Blockage
3
3
Connection Problem
3
3
Use of Device Problem
3
3
Tear, Rip or Hole in Device Packaging
3
3
Off-Label Use
3
3
Device Slipped
3
3
No Apparent Adverse Event
3
3
Free or Unrestricted Flow
3
3
Difficult to Advance
3
3
Material Too Soft/Flexible
3
3
Patient Device Interaction Problem
2
2
Separation Problem
2
2
Premature Separation
2
2
Device Dislodged or Dislocated
2
2
Explosion
2
2
Protective Measures Problem
2
2
Unraveled Material
2
2
Inadequacy of Device Shape and/or Size
2
2
Insufficient Flow or Under Infusion
2
2
Product Quality Problem
2
2
Material Too Rigid or Stiff
2
2
Failure to Advance
2
2
Device Displays Incorrect Message
2
2
Collapse
2
2
Decoupling
2
2
Deflation Problem
2
2
Entrapment of Device
2
2
Particulates
2
2
Device Difficult to Setup or Prepare
2
2
Inaccurate Flow Rate
2
2
Material Fragmentation
2
2
Gel Leak
1
1
Incorrect Measurement
1
1
Melted
1
1
Misassembled
1
1
Material Erosion
1
1
Display or Visual Feedback Problem
1
1
Data Back-Up Problem
1
1
Activation, Positioning or Separation Problem
1
1
Dent in Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
707
707
Hemorrhage/Bleeding
115
115
No Known Impact Or Consequence To Patient
111
111
No Consequences Or Impact To Patient
57
57
Blood Loss
36
36
Insufficient Information
34
34
Death
27
27
Cardiac Arrest
25
25
Exsanguination
18
18
Perforation of Vessels
17
17
Thrombosis/Thrombus
17
17
Hematoma
16
16
Air Embolism
14
14
Low Blood Pressure/ Hypotension
13
13
Ischemia
13
13
Cardiac Perforation
12
12
Cardiac Tamponade
11
11
No Patient Involvement
11
11
Device Embedded In Tissue or Plaque
10
10
Perforation
10
10
Obstruction/Occlusion
8
8
Swelling/ Edema
8
8
Vascular Dissection
8
8
Sepsis
7
7
Hypovolemia
6
6
Respiratory Failure
6
6
Unspecified Infection
6
6
Hemolysis
6
6
Bradycardia
6
6
Stroke/CVA
5
5
Pulmonary Embolism
5
5
Hypoxia
5
5
Foreign Body In Patient
5
5
No Code Available
4
4
Multiple Organ Failure
4
4
Tricuspid Valve Insufficiency/ Regurgitation
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Laceration(s)
4
4
Bacterial Infection
4
4
Decreased Respiratory Rate
4
4
Bronchopneumonia
4
4
Rupture
4
4
Brain Injury
3
3
Low Oxygen Saturation
3
3
Venipuncture
3
3
Pulmonary Hypertension
3
3
Unspecified Tissue Injury
2
2
Pericardial Effusion
2
2
Patient Problem/Medical Problem
2
2
Asystole
2
2
Hemorrhagic Stroke
2
2
Ischemia Stroke
2
2
Thrombocytopenia
2
2
Embolism/Embolus
2
2
Aortic Dissection
2
2
Sudden Cardiac Death
2
2
Atrial Perforation
2
2
Pneumothorax
2
2
Airway Obstruction
2
2
Arrhythmia
2
2
Cardiopulmonary Arrest
2
2
Non specific EKG/ECG Changes
2
2
Endocarditis
2
2
Pain
2
2
Extravasation
2
2
Intracranial Hemorrhage
1
1
Hyperbilirubinemia
1
1
High Blood Pressure/ Hypertension
1
1
Pleural Effusion
1
1
Pneumonia
1
1
Neurological Deficit/Dysfunction
1
1
Failure of Implant
1
1
Dyspnea
1
1
Chest Pain
1
1
Atrial Flutter
1
1
Aneurysm
1
1
Myocardial Contusion
1
1
Pulmonary Dysfunction
1
1
Pulmonary Edema
1
1
Renal Failure
1
1
Scar Tissue
1
1
Septic Shock
1
1
Swelling
1
1
Tachycardia
1
1
Thrombosis
1
1
Tissue Damage
1
1
Ulceration
1
1
Ulcer
1
1
Hemolytic Anemia
1
1
Distress
1
1
Sedation
1
1
Numbness
1
1
Loss of consciousness
1
1
Vascular System (Circulation), Impaired
1
1
Diminished Pulse Pressure
1
1
Complete Heart Block
1
1
Ventricular Fibrillation
1
1
Ventricular Tachycardia
1
1
Blurred Vision
1
1
Tingling
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardiac Assist, Inc
III
Nov-29-2021
2
Cardiac Assist, Inc
II
Feb-07-2020
3
Edwards Lifesciences, LLC
II
Jan-10-2020
4
Edwards Lifesciences, LLC
II
Nov-18-2019
5
LivaNova USA
II
Jan-23-2019
6
LivaNova USA Inc.
II
Jun-26-2020
7
Maquet Cardiovascular, LLC
II
May-31-2019
8
Medtronic Perfusion Systems
II
Jan-12-2022
9
Medtronic Perfusion Systems
II
Oct-01-2021
10
Medtronic Perfusion Systems
II
Jun-16-2021
11
OriGen Biomedical, Inc.
I
Jun-04-2019
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