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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. (SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 3
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 5
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 1324 1324

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 1333 1333
Gas Leak 905 905
Leak/Splash 794 794
Display or Visual Feedback Problem 540 540
Appropriate Term/Code Not Available 530 530
Battery Problem 520 520
Inability to Auto-Fill 519 519
Fluid Leak 502 502
Device Operates Differently Than Expected 467 467
Device Alarm System 451 451
Break 446 446
Failure to Sense 440 440
Material Rupture 425 425
No Display/Image 393 393
Device Contamination with Chemical or Other Material 335 335
Unexpected Shutdown 329 329
Inflation Problem 325 325
Pressure Problem 322 322
Failure to Power Up 318 318
Difficult to Insert 311 311
Loss of Power 307 307
Optical Problem 257 257
Pumping Stopped 247 247
Incorrect, Inadequate or Imprecise Resultor Readings 240 240
Premature Discharge of Battery 237 237
Moisture or Humidity Problem 217 217
Charging Problem 211 211
Noise, Audible 200 200
Communication or Transmission Problem 184 184
Difficult to Advance 177 177
Moisture Damage 177 177
Failure to Charge 173 173
Material Deformation 160 160
Calibration Problem 152 152
Failure to Advance 150 150
Erratic or Intermittent Display 149 149
Connection Problem 146 146
Electrical /Electronic Property Problem 144 144
Adverse Event Without Identified Device or Use Problem 142 142
Power Problem 142 142
Device Contamination with Body Fluid 119 119
Failure to Calibrate 104 104
Filling Problem 103 103
Defective Component 101 101
Failure to Zero 100 100
Difficult to Remove 98 98
Device Inoperable 96 96
Device Damaged Prior to Use 87 87
Mechanical Problem 80 80
Unable to Obtain Readings 70 70
Output below Specifications 67 67
Output Problem 62 62
Therapeutic or Diagnostic Output Failure 62 62
Failure of Device to Self-Test 61 61
Unraveled Material 59 59
Backflow 59 59
Kinked 58 58
Loose or Intermittent Connection 57 57
Component Missing 52 52
Defective Device 49 49
Overheating of Device 46 46
Deformation Due to Compressive Stress 45 45
Image Display Error/Artifact 44 44
Obstruction of Flow 43 43
Computer Operating System Problem 42 42
Temperature Problem 42 42
Protective Measures Problem 40 40
Material Puncture/Hole 40 40
Failure to Pump 39 39
Difficult to Flush 39 39
Disconnection 39 39
Failure to Read Input Signal 38 38
Device Markings/Labelling Problem 38 38
Device Sensing Problem 38 38
Crack 38 38
Incomplete or Inadequate Connection 37 37
Restricted Flow rate 36 36
Occlusion Within Device 35 35
Device Packaging Compromised 35 35
Audible Prompt/Feedback Problem 32 32
No Audible Alarm 31 31
No Device Output 29 29
Incorrect Or Inadequate Test Results 29 29
Use of Device Problem 29 29
Detachment of Device or Device Component 27 27
Insufficient Information 27 27
Application Program Freezes, Becomes Nonfunctional 27 27
Low Battery 27 27
No Apparent Adverse Event 25 25
Complete Blockage 25 25
Device Stops Intermittently 24 24
Migration or Expulsion of Device 23 23
Retraction Problem 23 23
Hole In Material 22 22
Air Leak 22 22
Entrapment of Device 22 22
Circuit Failure 22 22
Intermittent Communication Failure 20 20
Device Emits Odor 20 20
Infusion or Flow Problem 20 20

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 824 824
Death 452 452
Low Blood Pressure/ Hypotension 86 86
Injury 80 80
No Information 78 78
Myocardial Infarction 67 67
Cardiogenic Shock 61 61
Calcium Deposits/Calcification 52 53
Hemorrhage/Bleeding 48 48
Cardiac Arrest 40 40
No Code Available 40 41
Blood Loss 38 38
Needle Stick/Puncture 29 29
Insufficient Information 23 23
Thrombus 22 22
Chest Pain 15 15
Complaint, Ill-Defined 14 14
Ischemia 13 13
Nausea 12 12
Atrial Fibrillation 11 11
Hematoma 11 11
Cardiopulmonary Arrest 10 10
Vessel Or Plaque, Device Embedded In 10 10
Pain 10 10
Device Embedded In Tissue or Plaque 10 10
Heart Failure 10 10
Tachycardia 9 9
Stroke/CVA 9 9
Low Cardiac Output 9 9
Rupture 9 9
Loss of consciousness 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Abdominal Pain 8 8
Arrhythmia 8 8
Venipuncture 8 8
Ventricular Fibrillation 8 8
Angina 7 7
Vascular Dissection 7 7
Failure of Implant 7 7
Renal Failure 7 7
Aortic Dissection 6 6
Perforation of Vessels 6 6
Atherosclerosis 6 6
Bradycardia 6 6
Hypoxia 6 6
Vomiting 6 6
Vascular System (Circulation), Impaired 6 6
Patient Problem/Medical Problem 6 6
Brain Injury 5 5
Ventricular Tachycardia 5 5
Ischemic Heart Disease 5 5
High Blood Pressure/ Hypertension 5 5
Congestive Heart Failure 5 5
Fever 5 5
Respiratory Failure 4 4
Chest Tightness/Pressure 4 4
Loss Of Pulse 4 4
Discomfort 4 4
Pulmonary Edema 4 4
Respiratory Distress 4 4
Shock 3 3
Unspecified Infection 3 3
Left Ventricular Dysfunction 3 3
Urinary Retention 3 3
Obstruction/Occlusion 3 3
Stenosis 3 3
Weakness 3 3
Test Result 3 3
Foreign Body In Patient 3 3
Cardiac Tamponade 3 3
Glaucoma 3 3
Dyspnea 3 3
Air Embolism 3 3
Swelling 3 3
Perforation 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
Peritonitis 2 2
Low Oxygen Saturation 2 2
Numbness 2 2
Collapse 2 2
Multiple Organ Failure 2 2
Thrombosis/Thrombus 2 2
Pseudoaneurysm 2 2
Liver Damage/Dysfunction 2 2
Hemostasis 2 2
Hyperglycemia 1 1
Hemorrhage, Subarachnoid 1 1
Edema 1 1

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. III Apr-28-2021
4 Datascope Corp. I Jul-16-2019
5 Datascope Corporation II Aug-21-2020
6 Datascope Corporation II Feb-02-2020
7 Datascope Corporation II Jul-12-2019
8 Datascope Corporation II Oct-11-2018
9 Datascope Corporation II Apr-16-2018
10 Datascope Corporation II Jun-08-2016
11 Maquet Datascope Corp - Cardiac Assist Division I Oct-27-2018
12 Maquet Datascope Corp - Cardiac Assist Division I May-31-2018
13 Maquet Datascope Corp - Cardiac Assist Division I Sep-05-2017
14 Maquet Datascope Corp - Cardiac Assist Division I Jun-23-2017
15 Maquet Datascope Corp - Cardiac Assist Division II Mar-02-2017
16 Maquet Datascope Corp - Cardiac Assist Division II Mar-25-2016
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