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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, TELEFLEX
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 2164 2164
2018 3331 3331
2019 3552 3552
2020 3393 3393
2021 4345 4345

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 1376 1376
Gas Leak 1128 1128
Leak/Splash 931 931
Appropriate Term/Code Not Available 865 865
Inability to Auto-Fill 671 671
Battery Problem 636 636
Display or Visual Feedback Problem 629 629
Failure to Sense 545 545
Break 524 524
Fluid Leak 496 496
Device Operates Differently Than Expected 447 447
No Display/Image 439 439
Optical Problem 435 435
Device Alarm System 432 432
Pressure Problem 431 431
Unexpected Shutdown 422 422
Material Rupture 406 406
Failure to Power Up 390 390
Difficult to Insert 367 367
Inflation Problem 366 366
Device Contamination with Chemical or Other Material 348 348
Incorrect, Inadequate or Imprecise Resultor Readings 317 317
Premature Discharge of Battery 300 300
Loss of Power 299 299
Pumping Stopped 273 273
Failure to Charge 251 251
Charging Problem 232 232
Noise, Audible 223 223
Moisture or Humidity Problem 217 217
Erratic or Intermittent Display 210 210
Communication or Transmission Problem 198 198
Material Deformation 195 195
Calibration Problem 193 193
Difficult to Advance 192 192
Moisture Damage 178 178
Power Problem 171 171
Electrical /Electronic Property Problem 166 166
Failure to Advance 165 165
Adverse Event Without Identified Device or Use Problem 163 163
Connection Problem 156 156
Failure to Calibrate 134 134
Filling Problem 123 123
Failure to Zero 119 119
Device Contamination with Body Fluid 118 118
Defective Component 105 105
Mechanical Problem 97 97
Difficult to Remove 92 92
Device Inoperable 90 90
Device Damaged Prior to Use 89 89
Overheating of Device 79 79
Unable to Obtain Readings 75 75
Output below Specifications 73 73
Output Problem 73 73
Unraveled Material 70 70
Therapeutic or Diagnostic Output Failure 63 63
Off-Label Use 62 62
Loose or Intermittent Connection 61 61
Failure of Device to Self-Test 61 61
Backflow 59 59
No Apparent Adverse Event 58 58
Inappropriate Waveform 56 56
Component Missing 55 55
Difficult to Flush 54 54
Defective Device 53 53
Kinked 52 52
Deformation Due to Compressive Stress 51 51
Obstruction of Flow 50 50
Incomplete or Inadequate Connection 49 49
Failure to Read Input Signal 48 48
Image Display Error/Artifact 47 47
Restricted Flow rate 45 45
Disconnection 43 43
Temperature Problem 43 43
Protective Measures Problem 41 41
Use of Device Problem 41 41
Computer Operating System Problem 40 40
Material Puncture/Hole 40 40
Failure to Pump 40 40
Device Sensing Problem 38 38
Device Markings/Labelling Problem 37 37
Crack 37 37
Infusion or Flow Problem 35 35
Device Packaging Compromised 34 34
Audible Prompt/Feedback Problem 32 32
Application Program Freezes, Becomes Nonfunctional 31 31
Gas Output Problem 31 31
No Audible Alarm 31 31
Circuit Failure 31 31
No Device Output 31 31
Incorrect Or Inadequate Test Results 29 29
Detachment of Device or Device Component 28 28
Device Emits Odor 27 27
Retraction Problem 26 26
Component Incompatible 26 26
Low Battery 25 25
Migration 25 25
Complete Blockage 24 24
Occlusion Within Device 24 24
Material Twisted/Bent 23 23
Insufficient Information 23 23

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 4420 4420
No Known Impact Or Consequence To Patient 4154 4154
No Consequences Or Impact To Patient 4076 4076
No Clinical Signs, Symptoms or Conditions 3904 3904
Death 383 383
Low Blood Pressure/ Hypotension 86 86
Injury 78 78
No Information 70 70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 51 51
Calcium Deposits/Calcification 49 50
Cardiac Arrest 44 44
Insufficient Information 42 42
Hemorrhage/Bleeding 35 35
Myocardial Infarction 33 33
Cardiogenic Shock 32 32
Needle Stick/Puncture 31 31
Blood Loss 30 30
No Code Available 30 31
Thrombus 17 17
Chest Pain 17 17
Nausea 14 14
Ischemia 14 14
Low Cardiac Output 13 13
Tachycardia 12 12
Failure of Implant 11 11
Pain 10 10
Device Embedded In Tissue or Plaque 10 10
Vascular Dissection 9 9
Rupture 9 9
Loss of consciousness 9 9
Vessel Or Plaque, Device Embedded In 9 9
Atrial Fibrillation 9 9
Abdominal Pain 8 8
Cardiopulmonary Arrest 8 8
Stroke/CVA 8 8
Hematoma 8 8
Arrhythmia 7 7
High Blood Pressure/ Hypertension 7 7
Venipuncture 7 7
Cardiac Tamponade 7 7
Patient Problem/Medical Problem 6 6
Ventricular Fibrillation 6 6
Heart Failure 6 6
Vomiting 6 6
Hypoxia 6 6
Fever 5 5
Ventricular Tachycardia 5 5
Perforation of Vessels 5 5
Renal Failure 5 5
Aortic Dissection 5 5
Low Oxygen Saturation 5 5
Chest Tightness/Pressure 4 4
Pseudoaneurysm 4 4
Diminished Pulse Pressure 4 4
Vascular System (Circulation), Impaired 4 4
Brain Injury 4 4
Discomfort 4 4
Thrombosis/Thrombus 4 4
Pulmonary Edema 4 4
Weakness 3 3
Respiratory Distress 3 3
Perforation 3 3
Bradycardia 3 3
Air Embolism 3 3
Dyspnea 3 3
Test Result 3 3
Complaint, Ill-Defined 3 3
Obstruction/Occlusion 3 3
Foreign Body In Patient 3 3
Confusion/ Disorientation 3 3
Loss Of Pulse 3 3
Respiratory Failure 2 2
Numbness 2 2
Collapse 2 2
Stenosis 2 2
Urinary Retention 2 2
Peritonitis 2 2
Convulsion/Seizure 2 2
Mitral Valve Insufficiency/ Regurgitation 2 2
Tricuspid Valve Insufficiency/ Regurgitation 2 2
Unspecified Kidney or Urinary Problem 2 2
Non specific EKG/ECG Changes 2 2
Aortic Valve Stenosis 2 2
Congestive Heart Failure 2 2
Emotional Changes 2 2
Hemostasis 2 2
Pneumothorax 2 2
Paresis 2 2
Occlusion 2 2
Left Ventricular Failure 2 2
Liver Damage/Dysfunction 2 2
Shock 2 2
Swelling 2 2
Transient Ischemic Attack 1 1
Skin Discoloration 1 1
Renal Disease, End Stage 1 1
Tingling 1 1
Toxemia 1 1
Mitral Regurgitation 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc I Jun-26-2020
2 Datascope Corp. I Dec-30-2021
3 Datascope Corp. I Oct-20-2021
4 Datascope Corp. II Oct-07-2021
5 Datascope Corp. II Sep-30-2021
6 Datascope Corp. III Apr-28-2021
7 Datascope Corp. I Jul-16-2019
8 Datascope Corporation II Aug-21-2020
9 Datascope Corporation II Feb-02-2020
10 Datascope Corporation II Jul-12-2019
11 Datascope Corporation II Oct-11-2018
12 Datascope Corporation II Apr-16-2018
13 Maquet Datascope Corp - Cardiac Assist Division I Oct-27-2018
14 Maquet Datascope Corp - Cardiac Assist Division I May-31-2018
15 Maquet Datascope Corp - Cardiac Assist Division I Sep-05-2017
16 Maquet Datascope Corp - Cardiac Assist Division I Jun-23-2017
17 Maquet Datascope Corp - Cardiac Assist Division II Mar-02-2017
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