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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
Regulation Description Intra-aortic balloon and control system.
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
2016 419 419
2017 2164 2164
2018 3331 3331
2019 3552 3552
2020 3393 3393
2021 3117 3117

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 1392 1392
Gas Leak 1051 1051
Leak/Splash 884 884
Appropriate Term/Code Not Available 703 703
Display or Visual Feedback Problem 609 609
Inability to Auto-Fill 607 607
Battery Problem 590 590
Fluid Leak 526 526
Failure to Sense 523 523
Break 490 490
Device Alarm System 469 469
Device Operates Differently Than Expected 467 467
Material Rupture 427 427
No Display/Image 425 425
Pressure Problem 388 388
Unexpected Shutdown 382 382
Failure to Power Up 372 372
Optical Problem 359 359
Inflation Problem 348 348
Device Contamination with Chemical or Other Material 347 347
Difficult to Insert 344 344
Loss of Power 307 307
Incorrect, Inadequate or Imprecise Resultor Readings 289 289
Premature Discharge of Battery 278 278
Pumping Stopped 276 276
Failure to Charge 227 227
Charging Problem 224 224
Noise, Audible 219 219
Moisture or Humidity Problem 218 218
Communication or Transmission Problem 196 196
Erratic or Intermittent Display 189 189
Difficult to Advance 185 185
Calibration Problem 179 179
Material Deformation 178 178
Moisture Damage 177 177
Failure to Advance 162 162
Power Problem 162 162
Electrical /Electronic Property Problem 159 159
Adverse Event Without Identified Device or Use Problem 156 156
Connection Problem 155 155
Failure to Calibrate 126 126
Device Contamination with Body Fluid 124 124
Filling Problem 120 120
Failure to Zero 110 110
Defective Component 104 104
Difficult to Remove 100 100
Device Inoperable 96 96
Mechanical Problem 92 92
Device Damaged Prior to Use 89 89
Unable to Obtain Readings 74 74
Output below Specifications 70 70
Unraveled Material 67 67
Output Problem 64 64
Therapeutic or Diagnostic Output Failure 62 62
Overheating of Device 61 61
Failure of Device to Self-Test 61 61
Loose or Intermittent Connection 61 61
Backflow 59 59
Kinked 58 58
Off-Label Use 57 57
Component Missing 53 53
Deformation Due to Compressive Stress 53 53
Defective Device 52 52
Difficult to Flush 51 51
Obstruction of Flow 46 46
Image Display Error/Artifact 46 46
Failure to Read Input Signal 46 46
Restricted Flow rate 45 45
Incomplete or Inadequate Connection 45 45
Temperature Problem 43 43
Computer Operating System Problem 42 42
Failure to Pump 41 41
Protective Measures Problem 41 41
No Apparent Adverse Event 41 41
Disconnection 41 41
Material Puncture/Hole 40 40
Crack 39 39
Device Markings/Labelling Problem 39 39
Device Sensing Problem 39 39
Use of Device Problem 38 38
Device Packaging Compromised 35 35
Occlusion Within Device 35 35
No Audible Alarm 33 33
Audible Prompt/Feedback Problem 32 32
Application Program Freezes, Becomes Nonfunctional 30 30
Infusion or Flow Problem 30 30
Incorrect Or Inadequate Test Results 29 29
No Device Output 29 29
Insufficient Information 29 29
Detachment of Device or Device Component 28 28
Low Battery 27 27
Inappropriate Waveform 27 27
Circuit Failure 25 25
Complete Blockage 25 25
Gas Output Problem 25 25
Component Incompatible 24 24
Migration or Expulsion of Device 24 24
Retraction Problem 24 24
Device Stops Intermittently 24 24
Intermittent Communication Failure 23 23

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 4426 4426
No Consequences Or Impact To Patient 4231 4231
No Known Impact Or Consequence To Patient 4212 4212
No Clinical Signs, Symptoms or Conditions 2718 2718
Death 452 452
Low Blood Pressure/ Hypotension 92 92
Injury 80 80
No Information 78 78
Myocardial Infarction 71 71
Cardiogenic Shock 64 64
Calcium Deposits/Calcification 52 53
Hemorrhage/Bleeding 48 48
Cardiac Arrest 48 48
No Code Available 40 41
Blood Loss 38 38
Insufficient Information 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Needle Stick/Puncture 29 29
Thrombus 22 22
Ischemia 15 15
Chest Pain 15 15
Nausea 14 14
Complaint, Ill-Defined 14 14
Pain 12 12
Atrial Fibrillation 11 11
Device Embedded In Tissue or Plaque 11 11
Hematoma 11 11
Low Cardiac Output 11 11
Cardiopulmonary Arrest 10 10
Vessel Or Plaque, Device Embedded In 10 10
Heart Failure 10 10
Stroke/CVA 10 10
Tachycardia 10 10
Failure of Implant 9 9
Rupture 9 9
Loss of consciousness 9 9
Vascular Dissection 8 8
Abdominal Pain 8 8
Arrhythmia 8 8
Venipuncture 8 8
Ventricular Fibrillation 8 8
Angina 7 7
Cardiac Tamponade 7 7
High Blood Pressure/ Hypertension 7 7
Renal Failure 7 7
Perforation of Vessels 6 6
Aortic Dissection 6 6
Atherosclerosis 6 6
Bradycardia 6 6
Hypoxia 6 6
Vomiting 6 6
Patient Problem/Medical Problem 6 6
Vascular System (Circulation), Impaired 6 6
Brain Injury 5 5
Ventricular Tachycardia 5 5
Congestive Heart Failure 5 5
Fever 5 5
Ischemic Heart Disease 4 4
Respiratory Failure 4 4
Thrombosis/Thrombus 4 4
Discomfort 4 4
Chest Tightness/Pressure 4 4
Loss Of Pulse 4 4
Pulmonary Edema 4 4
Respiratory Distress 4 4
Unspecified Infection 3 3
Left Ventricular Dysfunction 3 3
Foreign Body In Patient 3 3
Test Result 3 3
Stenosis 3 3
Obstruction/Occlusion 3 3
Shock 3 3
Urinary Retention 3 3
Weakness 3 3
Glaucoma 3 3
Dyspnea 3 3
Air Embolism 3 3
Perforation 3 3
Swelling 3 3
Insufficiency, Valvular 2 2
Left Ventricular Failure 2 2
Mitral Regurgitation 2 2
Occlusion 2 2
Paresis 2 2
Cardiomyopathy 2 2
Aortic Valve Stenosis 2 2
Arteriosclerosis 2 2
Non specific EKG/ECG Changes 2 2
Emotional Changes 2 2
Multiple Organ Failure 2 2
Low Oxygen Saturation 2 2
Numbness 2 2
Collapse 2 2
Peritonitis 2 2
Mitral Valve Insufficiency/ Regurgitation 2 2
Tricuspid Valve Insufficiency/ Regurgitation 2 2
Unspecified Kidney or Urinary Problem 2 2
Pseudoaneurysm 2 2
Liver Damage/Dysfunction 2 2
Pneumothorax 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc I Jun-26-2020
2 Arrow International, Inc., Division of Teleflex Medical Inc. I Mar-11-2016
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 Datascope Corporation II Jun-08-2016
14 Maquet Datascope Corp - Cardiac Assist Division I Oct-27-2018
15 Maquet Datascope Corp - Cardiac Assist Division I May-31-2018
16 Maquet Datascope Corp - Cardiac Assist Division I Sep-05-2017
17 Maquet Datascope Corp - Cardiac Assist Division I Jun-23-2017
18 Maquet Datascope Corp - Cardiac Assist Division II Mar-02-2017
19 Maquet Datascope Corp - Cardiac Assist Division II Mar-25-2016
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