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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, balloon, intra-aortic and control
Product CodeDSP
Regulation Number 870.3535
Device Class 2


Premarket Reviews
ManufacturerDecision
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 6979 6979
2024 4808 4808

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 2657 2657
Device Displays Incorrect Message 2527 2527
Gas/Air Leak 2348 2348
Leak/Splash 2057 2057
Inability to Auto-Fill 1637 1637
Break 1405 1405
Battery Problem 1307 1307
Optical Problem 1235 1235
Failure to Sense 1078 1078
Display or Visual Feedback Problem 1037 1037
Device Operates Differently Than Expected 985 985
Incorrect, Inadequate or Imprecise Result or Readings 944 944
Inflation Problem 909 909
Failure to Power Up 888 888
Fluid/Blood Leak 880 880
Unexpected Shutdown 866 866
Device Alarm System 861 861
No Display/Image 844 844
Pressure Problem 784 784
Difficult to Insert 760 760
Failure to Charge 716 716
Erratic or Intermittent Display 599 599
Device Contamination with Body Fluid 597 597
Premature Discharge of Battery 575 575
Material Rupture 547 547
Noise, Audible 512 512
Pumping Stopped 477 477
Overheating of Device 458 458
Device Contamination with Chemical or Other Material 423 423
Power Problem 413 413
Connection Problem 369 369
Calibration Problem 363 363
Loss of Power 353 353
Communication or Transmission Problem 344 344
Material Deformation 342 342
Charging Problem 302 302
Difficult to Advance 268 268
Electrical /Electronic Property Problem 259 259
Moisture or Humidity Problem 259 259
Inappropriate Waveform 244 244
Adverse Event Without Identified Device or Use Problem 225 225
Output Problem 212 212
Failure to Zero 202 202
Failure to Calibrate 202 202
Failure to Advance 201 201
Backflow 197 197
Moisture Damage 190 190
Retraction Problem 190 190
Material Integrity Problem 189 189
Mechanical Problem 182 182

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19322 19322
No Consequences Or Impact To Patient 5021 5021
No Patient Involvement 4822 4822
No Known Impact Or Consequence To Patient 4544 4544
Insufficient Information 3462 3462
Death 767 767
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 288 288
Myocardial Infarction 181 181
Low Blood Pressure/ Hypotension 136 136
Cardiogenic Shock 124 124
No Information 112 112
Cardiac Arrest 98 98
Injury 83 83
Hemorrhage/Bleeding 81 81
Calcium Deposits/Calcification 68 69
Complaint, Ill-Defined 61 61
Needle Stick/Puncture 56 56
Blood Loss 51 51
No Code Available 49 50
Chest Pain 39 39
Failure of Implant 28 28
Tachycardia 26 26
Ischemia 26 26
High Blood Pressure/ Hypertension 25 25
Thrombus 24 24
Hematoma 22 22
Pain 21 21
Stroke/CVA 20 20
Vascular Dissection 20 20
Ventricular Fibrillation 19 19
Abdominal Pain 18 18
Angina 16 16
Atherosclerosis 16 16
Cardiopulmonary Arrest 15 15
Arrhythmia 15 15
Low Cardiac Output 15 15
Nausea 15 15
Atrial Fibrillation 14 14
Bradycardia 14 14
Heart Failure 14 14
Congestive Heart Failure 14 14
Device Embedded In Tissue or Plaque 13 13
Foreign Body In Patient 13 13
Loss of consciousness 12 12
Rupture 12 12
Ischemic Heart Disease 12 12
Renal Failure 12 12
Diminished Pulse Pressure 11 11
Pulmonary Edema 10 10
Vessel Or Plaque, Device Embedded In 10 10

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Jun-03-2024
2 ARROW INTERNATIONAL Inc. I Dec-15-2022
3 Arrow International Inc I Jun-26-2020
4 Arrow International Inc II Mar-10-2015
5 Arrow International Inc II Mar-02-2015
6 Arrow International Inc II Apr-06-2013
7 Arrow International, Inc. I Apr-16-2009
8 Arrow International, Inc., Division of Teleflex Medical Inc. I Mar-11-2016
9 Arrow International, Inc., Division of Teleflex Medical Inc. I Dec-23-2010
10 Datascope Corp. II Aug-31-2023
11 Datascope Corp. I Aug-30-2023
12 Datascope Corp. I Aug-30-2023
13 Datascope Corp. I Aug-30-2023
14 Datascope Corp. I Aug-30-2023
15 Datascope Corp. II Jul-21-2023
16 Datascope Corp. I Jul-20-2023
17 Datascope Corp. I Jul-19-2023
18 Datascope Corp. III Jun-14-2023
19 Datascope Corp. II Apr-26-2023
20 Datascope Corp. II Mar-22-2023
21 Datascope Corp. I Mar-09-2023
22 Datascope Corp. I Mar-09-2023
23 Datascope Corp. II Mar-06-2023
24 Datascope Corp. II Mar-06-2023
25 Datascope Corp. I Jan-19-2023
26 Datascope Corp. I Dec-30-2021
27 Datascope Corp. I Oct-20-2021
28 Datascope Corp. II Oct-07-2021
29 Datascope Corp. II Sep-30-2021
30 Datascope Corp. III Apr-28-2021
31 Datascope Corp. I Jul-16-2019
32 Datascope Corporation II Sep-08-2022
33 Datascope Corporation II Aug-21-2020
34 Datascope Corporation II Feb-02-2020
35 Datascope Corporation II Jul-12-2019
36 Datascope Corporation II Oct-11-2018
37 Datascope Corporation II Apr-16-2018
38 Datascope Corporation II Jun-08-2016
39 Datascope Corporation III Sep-03-2014
40 Datascope Corporation II Jun-21-2010
41 Datascope Corporation II Apr-15-2009
42 Maquet Cardiovascular, LLC II Jan-09-2013
43 Maquet Datascope Corp - Cardiac Assist Division I Oct-27-2018
44 Maquet Datascope Corp - Cardiac Assist Division I May-31-2018
45 Maquet Datascope Corp - Cardiac Assist Division I Sep-05-2017
46 Maquet Datascope Corp - Cardiac Assist Division I Jun-23-2017
47 Maquet Datascope Corp - Cardiac Assist Division II Mar-02-2017
48 Maquet Datascope Corp - Cardiac Assist Division II Mar-25-2016
49 Maquet Datascope Corp - Cardiac Assist Division II Feb-23-2015
50 Maquet Datascope Corp - Cardiac Assist Division II Feb-07-2015
51 Maquet Datascope Corp - Cardiac Assist Division I May-21-2014
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