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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
  1.  K163542  CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon ...
  2.  K172305  CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intr ...
  3.  K181122  CARDIOSAVE Intra-Aortic Balloon Pump

MDR Year MDR Reports MDR Events
2016 419 419
2017 2164 2164
2018 3331 3331
2019 3552 3552
2020 3393 3393
2021 3947 3947

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 1416 1416
Gas Leak 1134 1134
Leak/Splash 921 921
Appropriate Term/Code Not Available 797 797
Inability to Auto-Fill 645 645
Battery Problem 626 626
Display or Visual Feedback Problem 625 625
Fluid Leak 549 549
Failure to Sense 545 545
Break 514 514
Device Alarm System 477 477
Device Operates Differently Than Expected 467 467
No Display/Image 444 444
Material Rupture 431 431
Unexpected Shutdown 412 412
Pressure Problem 412 412
Optical Problem 403 403
Failure to Power Up 387 387
Inflation Problem 367 367
Difficult to Insert 363 363
Device Contamination with Chemical or Other Material 348 348
Incorrect, Inadequate or Imprecise Resultor Readings 311 311
Loss of Power 307 307
Premature Discharge of Battery 299 299
Pumping Stopped 285 285
Failure to Charge 249 249
Charging Problem 229 229
Noise, Audible 223 223
Moisture or Humidity Problem 218 218
Erratic or Intermittent Display 203 203
Communication or Transmission Problem 201 201
Difficult to Advance 190 190
Calibration Problem 190 190
Material Deformation 189 189
Moisture Damage 178 178
Power Problem 172 172
Failure to Advance 166 166
Adverse Event Without Identified Device or Use Problem 165 165
Electrical /Electronic Property Problem 162 162
Connection Problem 160 160
Failure to Calibrate 134 134
Device Contamination with Body Fluid 127 127
Filling Problem 124 124
Failure to Zero 118 118
Defective Component 105 105
Difficult to Remove 101 101
Device Inoperable 96 96
Mechanical Problem 96 96
Device Damaged Prior to Use 89 89
Unable to Obtain Readings 81 81
Output below Specifications 72 72
Overheating of Device 71 71
Output Problem 70 70
Unraveled Material 70 70
Therapeutic or Diagnostic Output Failure 63 63
Loose or Intermittent Connection 63 63
Off-Label Use 62 62
Failure of Device to Self-Test 61 61
Backflow 59 59
Kinked 58 58
Component Missing 55 55
No Apparent Adverse Event 54 54
Deformation Due to Compressive Stress 53 53
Difficult to Flush 53 53
Defective Device 52 52
Obstruction of Flow 49 49
Failure to Read Input Signal 47 47
Image Display Error/Artifact 47 47
Incomplete or Inadequate Connection 47 47
Inappropriate Waveform 46 46
Restricted Flow rate 45 45
Failure to Pump 44 44
Disconnection 43 43
Temperature Problem 43 43
Computer Operating System Problem 42 42
Protective Measures Problem 41 41
Device Sensing Problem 41 41
Material Puncture/Hole 40 40
Use of Device Problem 40 40
Crack 39 39
Device Markings/Labelling Problem 39 39
Device Packaging Compromised 35 35
Occlusion Within Device 35 35
Infusion or Flow Problem 34 34
No Audible Alarm 33 33
Audible Prompt/Feedback Problem 32 32
Application Program Freezes, Becomes Nonfunctional 31 31
Gas Output Problem 30 30
Circuit Failure 29 29
No Device Output 29 29
Detachment of Device or Device Component 29 29
Incorrect Or Inadequate Test Results 29 29
Insufficient Information 29 29
Low Battery 27 27
Device Emits Odor 26 26
Complete Blockage 25 25
Component Incompatible 25 25
Retraction Problem 25 25
Material Twisted/Bent 24 24
Migration or Expulsion of Device 24 24

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 3524 3524
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 50 50
Cardiac Arrest 48 48
Insufficient Information 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
No Code Available 40 41
Blood Loss 38 38
Needle Stick/Puncture 31 31
Thrombus 22 22
Ischemia 17 17
Chest Pain 16 16
Nausea 14 14
Complaint, Ill-Defined 14 14
Low Cardiac Output 13 13
Pain 12 12
Hematoma 11 11
Stroke/CVA 11 11
Atrial Fibrillation 11 11
Device Embedded In Tissue or Plaque 11 11
Vascular Dissection 10 10
Heart Failure 10 10
Tachycardia 10 10
Vessel Or Plaque, Device Embedded In 10 10
Cardiopulmonary Arrest 10 10
Failure of Implant 10 10
Rupture 9 9
Loss of consciousness 9 9
Venipuncture 8 8
Ventricular Fibrillation 8 8
Abdominal Pain 8 8
Arrhythmia 8 8
Angina 7 7
High Blood Pressure/ Hypertension 7 7
Renal Failure 7 7
Cardiac Tamponade 7 7
Perforation of Vessels 6 6
Vomiting 6 6
Aortic Dissection 6 6
Vascular System (Circulation), Impaired 6 6
Patient Problem/Medical Problem 6 6
Hypoxia 6 6
Bradycardia 6 6
Atherosclerosis 6 6
Fever 5 5
Congestive Heart Failure 5 5
Ischemic Heart Disease 5 5
Ventricular Tachycardia 5 5
Brain Injury 5 5
Discomfort 4 4
Chest Tightness/Pressure 4 4
Thrombosis/Thrombus 4 4
Respiratory Failure 4 4
Loss Of Pulse 4 4
Respiratory Distress 4 4
Pulmonary Edema 4 4
Shock 3 3
Swelling 3 3
Perforation 3 3
Unspecified Infection 3 3
Left Ventricular Dysfunction 3 3
Dyspnea 3 3
Glaucoma 3 3
Air Embolism 3 3
Foreign Body In Patient 3 3
Test Result 3 3
Obstruction/Occlusion 3 3
Low Oxygen Saturation 3 3
Stenosis 3 3
Weakness 3 3
Urinary Retention 3 3
Peritonitis 2 2
Numbness 2 2
Collapse 2 2
Pseudoaneurysm 2 2
Diminished Pulse Pressure 2 2
Multiple Organ Failure 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
Arteriosclerosis 2 2
Aortic Valve Stenosis 2 2
Cardiomyopathy 2 2
Non specific EKG/ECG Changes 2 2
Emotional Changes 2 2
Left Ventricular Failure 2 2
Liver Damage/Dysfunction 2 2
Mitral Regurgitation 2 2
Occlusion 2 2
Insufficiency, Valvular 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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