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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
2022 2788 2788

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 1441 1441
Gas Leak 1350 1350
Appropriate Term/Code Not Available 1202 1202
Leak/Splash 1092 1092
Inability to Auto-Fill 820 820
Battery Problem 775 775
Display or Visual Feedback Problem 704 704
Optical Problem 627 627
Failure to Sense 618 618
Break 592 592
Fluid Leak 550 550
Pressure Problem 530 530
Unexpected Shutdown 502 502
No Display/Image 487 487
Failure to Power Up 468 468
Device Alarm System 466 466
Device Operates Differently Than Expected 447 447
Incorrect, Inadequate or Imprecise Resultor Readings 437 437
Difficult to Insert 430 430
Material Rupture 415 415
Inflation Problem 410 410
Device Contamination with Chemical or Other Material 355 355
Premature Discharge of Battery 332 332
Failure to Charge 312 312
Loss of Power 300 300
Pumping Stopped 291 291
Erratic or Intermittent Display 252 252
Noise, Audible 248 248
Charging Problem 245 245
Material Deformation 239 239
Calibration Problem 226 226
Moisture or Humidity Problem 220 220
Communication or Transmission Problem 215 215
Difficult to Advance 209 209
Power Problem 209 209
Electrical /Electronic Property Problem 193 193
Moisture Damage 178 178
Connection Problem 176 176
Adverse Event Without Identified Device or Use Problem 167 167
Failure to Advance 165 165
Device Contamination with Body Fluid 160 160
Failure to Calibrate 153 153
Failure to Zero 135 135
Overheating of Device 130 130
Inappropriate Waveform 127 127
Filling Problem 125 125
Mechanical Problem 113 113
Defective Component 107 107
No Apparent Adverse Event 106 106
Difficult to Remove 102 102
Output Problem 95 95
Backflow 92 92
Device Inoperable 90 90
Device Damaged Prior to Use 89 89
Unable to Obtain Readings 82 82
Unraveled Material 79 79
Output below Specifications 74 74
Loose or Intermittent Connection 67 67
Therapeutic or Diagnostic Output Failure 66 66
Incomplete or Inadequate Connection 65 65
Off-Label Use 63 63
Difficult to Flush 63 63
Failure of Device to Self-Test 63 63
Component Missing 60 60
Defective Device 56 56
Obstruction of Flow 56 56
Deformation Due to Compressive Stress 53 53
Kinked 52 52
Failure to Read Input Signal 51 51
Device Sensing Problem 48 48
Infusion or Flow Problem 48 48
Image Display Error/Artifact 48 48
Restricted Flow rate 47 47
Failure to Pump 46 46
Disconnection 44 44
Temperature Problem 44 44
Material Puncture/Hole 43 43
Use of Device Problem 43 43
Gas Output Problem 42 42
Protective Measures Problem 42 42
Crack 41 41
Device Markings/Labelling Problem 40 40
Computer Operating System Problem 40 40
Circuit Failure 38 38
No Device Output 35 35
No Audible Alarm 34 34
Device Packaging Compromised 34 34
Retraction Problem 33 33
Migration 33 33
Audible Prompt/Feedback Problem 33 33
Application Program Freezes, Becomes Nonfunctional 32 32
Device Emits Odor 31 31
Component Incompatible 30 30
Material Twisted/Bent 30 30
Migration or Expulsion of Device 29 29
Incorrect Or Inadequate Test Results 29 29
Detachment of Device or Device Component 28 28
Failure to Run on Battery 28 28
Insufficient Information 27 27
Pumping Problem 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6431 6431
No Patient Involvement 4420 4420
No Known Impact Or Consequence To Patient 4154 4154
No Consequences Or Impact To Patient 4076 4076
Death 383 383
Insufficient Information 210 210
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 137 137
Low Blood Pressure/ Hypotension 96 96
Injury 78 78
No Information 70 70
Cardiac Arrest 54 54
Calcium Deposits/Calcification 49 50
Hemorrhage/Bleeding 39 39
Myocardial Infarction 33 33
Cardiogenic Shock 32 32
Needle Stick/Puncture 31 31
Blood Loss 30 30
No Code Available 30 31
Chest Pain 20 20
Thrombus 17 17
Tachycardia 14 14
Nausea 14 14
Ischemia 14 14
Low Cardiac Output 14 14
Vascular Dissection 13 13
Failure of Implant 13 13
Abdominal Pain 12 12
Device Embedded In Tissue or Plaque 11 11
Pain 10 10
Vessel Or Plaque, Device Embedded In 9 9
Atrial Fibrillation 9 9
Rupture 9 9
Loss of consciousness 9 9
Cardiac Tamponade 8 8
Cardiopulmonary Arrest 8 8
Stroke/CVA 8 8
Hematoma 8 8
Ventricular Fibrillation 8 8
Venipuncture 7 7
High Blood Pressure/ Hypertension 7 7
Bradycardia 7 7
Arrhythmia 7 7
Air Embolism 7 7
Fever 6 6
Hypoxia 6 6
Heart Failure 6 6
Vomiting 6 6
Pseudoaneurysm 6 6
Patient Problem/Medical Problem 6 6
Aortic Dissection 5 5
Low Oxygen Saturation 5 5
Ventricular Tachycardia 5 5
Perforation of Vessels 5 5
Shock 5 5
Renal Failure 5 5
Pulmonary Edema 4 4
Chest Tightness/Pressure 4 4
Diminished Pulse Pressure 4 4
Vascular System (Circulation), Impaired 4 4
Brain Injury 4 4
Discomfort 4 4
Thrombosis/Thrombus 4 4
Mitral Valve Insufficiency/ Regurgitation 3 3
Tricuspid Valve Insufficiency/ Regurgitation 3 3
Foreign Body In Patient 3 3
Test Result 3 3
Complaint, Ill-Defined 3 3
Obstruction/Occlusion 3 3
Confusion/ Disorientation 3 3
Loss Of Pulse 3 3
Weakness 3 3
Respiratory Distress 3 3
Pneumothorax 3 3
Perforation 3 3
Dyspnea 3 3
Non specific EKG/ECG Changes 2 2
Aortic Valve Stenosis 2 2
Hemostasis 2 2
Bone Fracture(s) 2 2
Congestive Heart Failure 2 2
Emotional Changes 2 2
Paresis 2 2
Occlusion 2 2
Left Ventricular Failure 2 2
Liver Damage/Dysfunction 2 2
Urinary Retention 2 2
Swelling 2 2
Peritonitis 2 2
Respiratory Failure 2 2
Numbness 2 2
Collapse 2 2
Stenosis 2 2
Unspecified Kidney or Urinary Problem 2 2
Swelling/ Edema 2 2
Convulsion/Seizure 2 2
Ischemia Stroke 1 1
Embolism/Embolus 1 1
Unspecified Vascular Problem 1 1
Heart Failure/Congestive Heart Failure 1 1
Unspecified Heart Problem 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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