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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
  1.  K200634  Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
  2.  K201112  AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, Au ...
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 3561 3561

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 1406 1406
Gas Leak 1097 1097
Leak/Splash 908 908
Appropriate Term/Code Not Available 755 755
Inability to Auto-Fill 627 627
Display or Visual Feedback Problem 617 617
Battery Problem 607 607
Fluid Leak 543 543
Failure to Sense 535 535
Break 504 504
Device Alarm System 471 471
Device Operates Differently Than Expected 467 467
No Display/Image 435 435
Material Rupture 429 429
Unexpected Shutdown 401 401
Pressure Problem 395 395
Failure to Power Up 383 383
Optical Problem 374 374
Inflation Problem 357 357
Difficult to Insert 349 349
Device Contamination with Chemical or Other Material 348 348
Loss of Power 307 307
Incorrect, Inadequate or Imprecise Resultor Readings 301 301
Premature Discharge of Battery 292 292
Pumping Stopped 282 282
Failure to Charge 238 238
Charging Problem 227 227
Noise, Audible 221 221
Moisture or Humidity Problem 218 218
Communication or Transmission Problem 199 199
Erratic or Intermittent Display 197 197
Difficult to Advance 188 188
Material Deformation 185 185
Calibration Problem 184 184
Moisture Damage 178 178
Failure to Advance 166 166
Power Problem 164 164
Adverse Event Without Identified Device or Use Problem 163 163
Electrical /Electronic Property Problem 161 161
Connection Problem 156 156
Failure to Calibrate 131 131
Device Contamination with Body Fluid 126 126
Filling Problem 123 123
Failure to Zero 115 115
Defective Component 105 105
Difficult to Remove 101 101
Device Inoperable 96 96
Mechanical Problem 93 93
Device Damaged Prior to Use 89 89
Unable to Obtain Readings 77 77
Output below Specifications 71 71
Unraveled Material 70 70
Output Problem 68 68
Overheating of Device 65 65
Loose or Intermittent Connection 63 63
Therapeutic or Diagnostic Output Failure 63 63
Off-Label Use 62 62
Failure of Device to Self-Test 61 61
Backflow 59 59
Kinked 58 58
Difficult to Flush 53 53
Deformation Due to Compressive Stress 53 53
Component Missing 53 53
Defective Device 52 52
No Apparent Adverse Event 48 48
Obstruction of Flow 47 47
Failure to Read Input Signal 46 46
Image Display Error/Artifact 46 46
Incomplete or Inadequate Connection 46 46
Restricted Flow rate 45 45
Temperature Problem 43 43
Failure to Pump 42 42
Disconnection 42 42
Computer Operating System Problem 42 42
Protective Measures Problem 41 41
Device Sensing Problem 40 40
Material Puncture/Hole 40 40
Crack 39 39
Device Markings/Labelling Problem 39 39
Use of Device Problem 39 39
Device Packaging Compromised 35 35
Occlusion Within Device 35 35
Infusion or Flow Problem 34 34
No Audible Alarm 33 33
Inappropriate Waveform 32 32
Audible Prompt/Feedback Problem 32 32
Application Program Freezes, Becomes Nonfunctional 30 30
Insufficient Information 29 29
Incorrect Or Inadequate Test Results 29 29
No Device Output 29 29
Detachment of Device or Device Component 28 28
Low Battery 27 27
Gas Output Problem 27 27
Circuit Failure 27 27
Complete Blockage 25 25
Component Incompatible 25 25
Retraction Problem 25 25
Migration or Expulsion of Device 24 24
Device Emits Odor 24 24
Device Stops Intermittently 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 3142 3142
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
No Code Available 40 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Insufficient Information 38 38
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 12 12
Pain 12 12
Hematoma 11 11
Atrial Fibrillation 11 11
Device Embedded In Tissue or Plaque 11 11
Heart Failure 10 10
Cardiopulmonary Arrest 10 10
Stroke/CVA 10 10
Vessel Or Plaque, Device Embedded In 10 10
Failure of Implant 10 10
Tachycardia 10 10
Rupture 9 9
Loss of consciousness 9 9
Vascular Dissection 9 9
Venipuncture 8 8
Ventricular Fibrillation 8 8
Abdominal Pain 8 8
Arrhythmia 8 8
Angina 7 7
Renal Failure 7 7
High Blood Pressure/ Hypertension 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
Congestive Heart Failure 5 5
Fever 5 5
Ischemic Heart Disease 5 5
Ventricular Tachycardia 5 5
Brain Injury 5 5
Respiratory Failure 4 4
Chest Tightness/Pressure 4 4
Discomfort 4 4
Loss Of Pulse 4 4
Thrombosis/Thrombus 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
Glaucoma 3 3
Dyspnea 3 3
Air Embolism 3 3
Foreign Body In Patient 3 3
Test Result 3 3
Stenosis 3 3
Obstruction/Occlusion 3 3
Urinary Retention 3 3
Weakness 3 3
Peritonitis 2 2
Low Oxygen Saturation 2 2
Numbness 2 2
Collapse 2 2
Multiple Organ Failure 2 2
Pseudoaneurysm 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
Hemostasis 2 2
Left Ventricular Failure 2 2
Liver Damage/Dysfunction 2 2
Paresis 2 2
Occlusion 2 2
Insufficiency, Valvular 2 2
Mitral Regurgitation 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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