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TPLC
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Device
system, balloon, intra-aortic and control
Product Code
DSP
Regulation Number
870.3535
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARROW INTERNATIONAL INC.
SUBSTANTIALLY EQUIVALENT
2
ARROW INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
3
ARROW INTERNATIONAL, LLC
SUBSTANTIALLY EQUIVALENT
1
ARROW INTERNATIONAL, TELEFLEX
SUBSTANTIALLY EQUIVALENT
1
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
SUBSTANTIALLY EQUIVALENT
2
DATASCOPE CORP.
SUBSTANTIALLY EQUIVALENT
5
DATASCOPE CORP., CARDIAC ASSIST DIVISION
SUBSTANTIALLY EQUIVALENT
3
INSIGHTRA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1738
1738
2015
404
404
2016
419
419
2017
2164
2164
2018
3331
3331
2019
3552
3552
2020
3393
3393
2021
4345
4345
2022
5113
5113
2023
6978
6978
2024
1146
1146
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Displays Incorrect Message
2493
2493
Appropriate Term/Code Not Available
2260
2260
Gas/Air Leak
2102
2102
Leak/Splash
1828
1828
Inability to Auto-Fill
1421
1421
Break
1211
1211
Battery Problem
1171
1171
Optical Problem
1099
1099
Device Operates Differently Than Expected
985
985
Display or Visual Feedback Problem
945
945
Failure to Sense
934
934
Fluid/Blood Leak
851
851
Device Alarm System
810
810
Incorrect, Inadequate or Imprecise Result or Readings
801
801
No Display/Image
775
775
Failure to Power Up
775
775
Unexpected Shutdown
761
761
Pressure Problem
741
741
Inflation Problem
738
738
Difficult to Insert
699
699
Failure to Charge
627
627
Material Rupture
536
536
Device Contamination with Body Fluid
526
526
Premature Discharge of Battery
525
525
Erratic or Intermittent Display
524
524
Pumping Stopped
459
459
Noise, Audible
459
459
Device Contamination with Chemical or Other Material
416
416
Power Problem
361
361
Loss of Power
353
353
Overheating of Device
348
348
Calibration Problem
332
332
Communication or Transmission Problem
313
313
Material Deformation
309
309
Connection Problem
304
304
Charging Problem
286
286
Difficult to Advance
255
255
Moisture or Humidity Problem
253
253
Inappropriate Waveform
232
232
Electrical /Electronic Property Problem
232
232
Adverse Event Without Identified Device or Use Problem
221
221
Output Problem
199
199
Failure to Advance
197
197
Failure to Calibrate
197
197
Backflow
194
194
Failure to Zero
190
190
Moisture Damage
189
189
Mechanical Problem
171
171
No Apparent Adverse Event
167
167
Retraction Problem
160
160
Difficult to Remove
160
160
Filling Problem
148
148
Device Inoperable
136
136
Defective Component
122
122
Material Integrity Problem
121
121
Unraveled Material
114
114
No Device Output
112
112
Unable to Obtain Readings
106
106
Loose or Intermittent Connection
98
98
Device Damaged Prior to Use
97
97
Image Display Error/Artifact
94
94
Decrease in Suction
94
94
Device Sensing Problem
91
91
Circuit Failure
85
85
Restricted Flow rate
82
82
Insufficient Information
81
81
Failure to Pump
80
80
Difficult to Flush
79
79
Crack
78
78
Obstruction of Flow
78
78
Kinked
76
76
Therapeutic or Diagnostic Output Failure
76
76
Incomplete or Inadequate Connection
75
75
Inadequate User Interface
75
75
Component Missing
75
75
Defective Device
74
74
Output below Specifications
74
74
Failure of Device to Self-Test
70
70
Material Twisted/Bent
68
68
Failure to Read Input Signal
68
68
Failure to Run on Battery
67
67
Migration
66
66
Off-Label Use
65
65
Mechanical Jam
63
63
Device Emits Odor
62
62
Material Puncture/Hole
60
60
Use of Device Problem
59
59
Infusion or Flow Problem
59
59
Temperature Problem
58
58
Deformation Due to Compressive Stress
57
57
Gas Output Problem
57
57
Component Incompatible
54
54
Disconnection
54
54
Occlusion Within Device
52
52
Protective Measures Problem
50
50
Audible Prompt/Feedback Problem
50
50
Device Markings/Labelling Problem
48
48
Complete Loss of Power
46
46
Suction Problem
45
45
Detachment of Device or Device Component
44
44
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
15752
15752
No Consequences Or Impact To Patient
5021
5021
No Patient Involvement
4822
4822
No Known Impact Or Consequence To Patient
4544
4544
Insufficient Information
2818
2818
Death
767
767
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
249
249
Myocardial Infarction
174
174
Low Blood Pressure/ Hypotension
131
131
Cardiogenic Shock
123
123
No Information
112
112
Cardiac Arrest
89
89
Injury
83
83
Hemorrhage/Bleeding
77
77
Calcium Deposits/Calcification
68
69
Complaint, Ill-Defined
61
61
Needle Stick/Puncture
55
55
Blood Loss
51
51
No Code Available
49
50
Chest Pain
39
39
Failure of Implant
25
25
Ischemia
25
25
Tachycardia
25
25
Thrombus
24
24
High Blood Pressure/ Hypertension
24
24
Hematoma
20
20
Stroke/CVA
19
19
Pain
19
19
Ventricular Fibrillation
18
18
Abdominal Pain
18
18
Angina
16
16
Atherosclerosis
16
16
Arrhythmia
15
15
Cardiopulmonary Arrest
15
15
Nausea
15
15
Vascular Dissection
15
15
Low Cardiac Output
15
15
Atrial Fibrillation
14
14
Bradycardia
14
14
Congestive Heart Failure
14
14
Heart Failure
14
14
Device Embedded In Tissue or Plaque
13
13
Foreign Body In Patient
12
12
Rupture
12
12
Ischemic Heart Disease
12
12
Renal Failure
12
12
Diminished Pulse Pressure
11
11
Pseudoaneurysm
10
10
Pulmonary Edema
10
10
Shock
10
10
Loss of consciousness
10
10
Air Embolism
10
10
Vessel Or Plaque, Device Embedded In
10
10
Thrombosis/Thrombus
9
9
Dyspnea
8
8
Cardiac Tamponade
8
8
Venipuncture
8
8
Vomiting
7
7
Ventricular Tachycardia
7
7
Perforation of Vessels
7
7
Fever
7
7
Cardiomyopathy
7
7
Perforation
7
7
Hypoxia
7
7
Peripheral Vascular Disease
6
6
Unspecified Infection
6
6
Brain Injury
6
6
Aortic Dissection
6
6
Low Oxygen Saturation
6
6
Chest Tightness/Pressure
6
6
Patient Problem/Medical Problem
6
6
Vascular System (Circulation), Impaired
6
6
Loss Of Pulse
5
5
Heart Failure/Congestive Heart Failure
5
5
Unspecified Vascular Problem
5
5
ST Segment Elevation
5
5
Paresis
5
5
Surgical procedure, repeated
5
5
Left Ventricular Dysfunction
5
5
Mitral Regurgitation
5
5
Aneurysm
5
5
Non specific EKG/ECG Changes
5
5
Bone Fracture(s)
4
4
Pulmonary Embolism
4
4
Arteriosclerosis
4
4
Aortic Valve Stenosis
4
4
Mitral Insufficiency
4
4
Occlusion
4
4
Respiratory Distress
4
4
Respiratory Failure
4
4
Obstruction/Occlusion
4
4
Discomfort
4
4
Confusion/ Disorientation
4
4
Cognitive Changes
3
3
Thromboembolism
3
3
Mitral Valve Insufficiency/ Regurgitation
3
3
Tricuspid Valve Insufficiency/ Regurgitation
3
3
Test Result
3
3
Unspecified Kidney or Urinary Problem
3
3
Stenosis
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
ARROW INTERNATIONAL Inc.
I
Dec-15-2022
2
Arrow International Inc
I
Jun-26-2020
3
Arrow International Inc
II
Mar-10-2015
4
Arrow International Inc
II
Mar-02-2015
5
Arrow International Inc
II
Apr-06-2013
6
Arrow International, Inc.
I
Apr-16-2009
7
Arrow International, Inc., Division of Teleflex Medical Inc.
I
Mar-11-2016
8
Arrow International, Inc., Division of Teleflex Medical Inc.
I
Dec-23-2010
9
Datascope Corp.
II
Aug-31-2023
10
Datascope Corp.
I
Aug-30-2023
11
Datascope Corp.
I
Aug-30-2023
12
Datascope Corp.
I
Aug-30-2023
13
Datascope Corp.
I
Aug-30-2023
14
Datascope Corp.
II
Jul-21-2023
15
Datascope Corp.
I
Jul-20-2023
16
Datascope Corp.
I
Jul-19-2023
17
Datascope Corp.
III
Jun-14-2023
18
Datascope Corp.
II
Apr-26-2023
19
Datascope Corp.
II
Mar-22-2023
20
Datascope Corp.
I
Mar-09-2023
21
Datascope Corp.
I
Mar-09-2023
22
Datascope Corp.
II
Mar-06-2023
23
Datascope Corp.
II
Mar-06-2023
24
Datascope Corp.
I
Jan-19-2023
25
Datascope Corp.
I
Dec-30-2021
26
Datascope Corp.
I
Oct-20-2021
27
Datascope Corp.
II
Oct-07-2021
28
Datascope Corp.
II
Sep-30-2021
29
Datascope Corp.
III
Apr-28-2021
30
Datascope Corp.
I
Jul-16-2019
31
Datascope Corporation
II
Sep-08-2022
32
Datascope Corporation
II
Aug-21-2020
33
Datascope Corporation
II
Feb-02-2020
34
Datascope Corporation
II
Jul-12-2019
35
Datascope Corporation
II
Oct-11-2018
36
Datascope Corporation
II
Apr-16-2018
37
Datascope Corporation
II
Jun-08-2016
38
Datascope Corporation
III
Sep-03-2014
39
Datascope Corporation
II
Jun-21-2010
40
Datascope Corporation
II
Apr-15-2009
41
Maquet Cardiovascular, LLC
II
Jan-09-2013
42
Maquet Datascope Corp - Cardiac Assist Division
I
Oct-27-2018
43
Maquet Datascope Corp - Cardiac Assist Division
I
May-31-2018
44
Maquet Datascope Corp - Cardiac Assist Division
I
Sep-05-2017
45
Maquet Datascope Corp - Cardiac Assist Division
I
Jun-23-2017
46
Maquet Datascope Corp - Cardiac Assist Division
II
Mar-02-2017
47
Maquet Datascope Corp - Cardiac Assist Division
II
Mar-25-2016
48
Maquet Datascope Corp - Cardiac Assist Division
II
Feb-23-2015
49
Maquet Datascope Corp - Cardiac Assist Division
II
Feb-07-2015
50
Maquet Datascope Corp - Cardiac Assist Division
I
May-21-2014
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