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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 2
ARROW INTERNATIONAL, TELEFLEX
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3331 3331
2019 3552 3552
2020 3393 3393
2021 4345 4345
2022 5112 5112
2023 2635 2635

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 1777 1777
Gas/Air Leak 1592 1592
Device Displays Incorrect Message 1282 1282
Leak/Splash 1265 1265
Inability to Auto-Fill 1020 1020
Battery Problem 897 897
Optical Problem 883 883
Break 838 838
Display or Visual Feedback Problem 772 772
Failure to Sense 729 729
Pressure Problem 616 616
Unexpected Shutdown 591 591
Failure to Power Up 546 546
No Display/Image 519 519
Incorrect, Inadequate or Imprecise Result or Readings 514 514
Fluid/Blood Leak 496 496
Difficult to Insert 491 491
Inflation Problem 457 457
Device Alarm System 436 436
Failure to Charge 427 427
Premature Discharge of Battery 402 402
Erratic or Intermittent Display 366 366
Device Contamination with Chemical or Other Material 352 352
Device Contamination with Body Fluid 342 342
Material Rupture 341 341
Pumping Stopped 314 314
Noise, Audible 300 300
Material Deformation 280 280
Power Problem 265 265
Calibration Problem 253 253
Charging Problem 231 231
Device Operates Differently Than Expected 229 229
Overheating of Device 221 221
Communication or Transmission Problem 207 207
Difficult to Advance 205 205
Loss of Power 205 205
Connection Problem 204 204
Electrical /Electronic Property Problem 202 202
Inappropriate Waveform 192 192
Mechanical Problem 152 152
Adverse Event Without Identified Device or Use Problem 152 152
Backflow 147 147
Moisture or Humidity Problem 146 146
Failure to Calibrate 144 144
No Apparent Adverse Event 133 133
Failure to Zero 130 130
Failure to Advance 125 125
Filling Problem 121 121
Retraction Problem 114 114
Output Problem 113 113
Difficult to Remove 101 101
Defective Component 101 101
Unraveled Material 83 83
Therapeutic or Diagnostic Output Failure 73 73
Incomplete or Inadequate Connection 73 73
Material Integrity Problem 72 72
Output below Specifications 71 71
Loose or Intermittent Connection 69 69
Unable to Obtain Readings 67 67
Difficult to Flush 66 66
Circuit Failure 64 64
Off-Label Use 63 63
Defective Device 63 63
Component Missing 61 61
No Device Output 58 58
Obstruction of Flow 57 57
Infusion or Flow Problem 54 54
Failure of Device to Self-Test 54 54
Deformation Due to Compressive Stress 52 52
Component Incompatible 51 51
Restricted Flow rate 49 49
Image Display Error/Artifact 49 49
Gas Output Problem 48 48
Failure to Read Input Signal 48 48
Device Sensing Problem 48 48
Failure to Pump 48 48
Material Twisted/Bent 47 47
Protective Measures Problem 45 45
Temperature Problem 45 45
Migration 45 45
Crack 44 44
Device Markings/Labelling Problem 43 43
Device Inoperable 43 43
Use of Device Problem 43 43
Disconnection 42 42
Material Puncture/Hole 42 42
Device Damaged Prior to Use 39 39
Failure to Run on Battery 38 38
Device Emits Odor 37 37
Audible Prompt/Feedback Problem 36 36
Application Program Freezes, Becomes Nonfunctional 35 35
Insufficient Information 35 35
Detachment of Device or Device Component 33 33
Deflation Problem 32 32
No Audible Alarm 31 31
Decrease in Suction 29 29
Moisture Damage 29 29
Physical Resistance/Sticking 29 29
Migration or Expulsion of Device 28 28
Pumping Problem 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10597 10597
No Patient Involvement 3899 3899
No Consequences Or Impact To Patient 3716 3716
No Known Impact Or Consequence To Patient 3111 3111
Insufficient Information 1495 1495
Death 251 251
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 184 184
Low Blood Pressure/ Hypotension 85 85
Injury 70 70
No Information 51 51
Cardiac Arrest 46 46
Calcium Deposits/Calcification 37 38
Needle Stick/Puncture 36 36
Myocardial Infarction 33 33
Hemorrhage/Bleeding 32 32
Cardiogenic Shock 26 26
No Code Available 24 25
Blood Loss 23 23
Tachycardia 21 21
Chest Pain 19 19
Failure of Implant 16 16
Abdominal Pain 15 15
Thrombus 14 14
Nausea 14 14
Ischemia 14 14
Pain 11 11
Low Cardiac Output 11 11
Vascular Dissection 11 11
Diminished Pulse Pressure 10 10
Device Embedded In Tissue or Plaque 10 10
Ventricular Fibrillation 10 10
Rupture 10 10
Arrhythmia 10 10
Atrial Fibrillation 9 9
Bradycardia 8 8
Stroke/CVA 8 8
Dyspnea 7 7
Air Embolism 7 7
Vessel Or Plaque, Device Embedded In 7 7
Cardiac Tamponade 7 7
Loss of consciousness 6 6
Pseudoaneurysm 6 6
Patient Problem/Medical Problem 6 6
Thrombosis/Thrombus 6 6
Hypoxia 6 6
High Blood Pressure/ Hypertension 6 6
Fever 6 6
Heart Failure 6 6
Vomiting 6 6
Perforation 5 5
Shock 5 5
Hematoma 5 5
Low Oxygen Saturation 5 5
Aortic Dissection 4 4
Foreign Body In Patient 4 4
Unspecified Vascular Problem 4 4
Renal Failure 4 4
Paresis 4 4
Ventricular Tachycardia 4 4
Brain Injury 4 4
Perforation of Vessels 3 3
Weakness 3 3
Liver Damage/Dysfunction 3 3
Liver Laceration(s) 3 3
Pneumothorax 3 3
Cardiopulmonary Arrest 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
Tricuspid Valve Insufficiency/ Regurgitation 3 3
Unspecified Kidney or Urinary Problem 3 3
Vascular System (Circulation), Impaired 3 3
Confusion/ Disorientation 3 3
Obstruction/Occlusion 3 3
Chest Tightness/Pressure 3 3
Dizziness 3 3
Discomfort 3 3
Peritonitis 2 2
Numbness 2 2
Collapse 2 2
Loss Of Pulse 2 2
Test Result 2 2
Unspecified Tissue Injury 2 2
Embolism/Embolus 2 2
Convulsion/Seizure 2 2
Swelling/ Edema 2 2
Cardiomyopathy 2 2
Pulmonary Embolism 2 2
Aneurysm 2 2
Emotional Changes 2 2
Extravasation 2 2
Laceration(s) 2 2
Occlusion 2 2
Urinary Retention 2 2
Venipuncture 2 2
Tingling 1 1
Toxemia 1 1
Stenosis 1 1
Physical Entrapment 1 1
Anxiety 1 1
Pulmonary Edema 1 1
Renal Disease, End Stage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Dec-15-2022
2 Arrow International Inc I Jun-26-2020
3 Datascope Corp. II Apr-26-2023
4 Datascope Corp. II Mar-22-2023
5 Datascope Corp. I Mar-09-2023
6 Datascope Corp. I Mar-09-2023
7 Datascope Corp. II Mar-06-2023
8 Datascope Corp. II Mar-06-2023
9 Datascope Corp. I Jan-19-2023
10 Datascope Corp. I Dec-30-2021
11 Datascope Corp. I Oct-20-2021
12 Datascope Corp. II Oct-07-2021
13 Datascope Corp. II Sep-30-2021
14 Datascope Corp. III Apr-28-2021
15 Datascope Corp. I Jul-16-2019
16 Datascope Corporation II Sep-08-2022
17 Datascope Corporation II Aug-21-2020
18 Datascope Corporation II Feb-02-2020
19 Datascope Corporation II Jul-12-2019
20 Datascope Corporation II Oct-11-2018
21 Datascope Corporation II Apr-16-2018
22 Maquet Datascope Corp - Cardiac Assist Division I Oct-27-2018
23 Maquet Datascope Corp - Cardiac Assist Division I May-31-2018
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