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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 4103 4103

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 1519 1519
Gas/Air Leak 1451 1451
Appropriate Term/Code Not Available 1325 1325
Leak/Splash 1182 1182
Inability to Auto-Fill 890 890
Battery Problem 822 822
Display or Visual Feedback Problem 718 718
Optical Problem 716 716
Failure to Sense 645 645
Break 619 619
Fluid/Blood Leak 569 569
Pressure Problem 560 560
Unexpected Shutdown 526 526
No Display/Image 520 520
Device Alarm System 502 502
Failure to Power Up 496 496
Incorrect, Inadequate or Imprecise Result or Readings 475 475
Difficult to Insert 470 470
Device Operates Differently Than Expected 447 447
Inflation Problem 437 437
Material Rupture 421 421
Device Contamination with Chemical or Other Material 369 369
Premature Discharge of Battery 354 354
Failure to Charge 346 346
Pumping Stopped 315 315
Loss of Power 300 300
Erratic or Intermittent Display 277 277
Noise, Audible 260 260
Material Deformation 251 251
Charging Problem 249 249
Calibration Problem 239 239
Power Problem 238 238
Moisture or Humidity Problem 223 223
Communication or Transmission Problem 219 219
Difficult to Advance 217 217
Electrical /Electronic Property Problem 198 198
Connection Problem 192 192
Moisture Damage 178 178
Adverse Event Without Identified Device or Use Problem 168 168
Failure to Advance 165 165
Device Contamination with Body Fluid 163 163
Failure to Calibrate 155 155
Overheating of Device 150 150
Inappropriate Waveform 144 144
Failure to Zero 142 142
Filling Problem 128 128
Mechanical Problem 120 120
No Apparent Adverse Event 115 115
Backflow 114 114
Defective Component 110 110
Difficult to Remove 107 107
Output Problem 99 99
Device Damaged Prior to Use 91 91
Device Inoperable 90 90
Unraveled Material 84 84
Unable to Obtain Readings 82 82
Output below Specifications 74 74
Therapeutic or Diagnostic Output Failure 71 71
Loose or Intermittent Connection 67 67
Difficult to Flush 65 65
Incomplete or Inadequate Connection 65 65
Off-Label Use 63 63
Component Missing 63 63
Failure of Device to Self-Test 63 63
Obstruction of Flow 56 56
Defective Device 56 56
Deformation Due to Compressive Stress 53 53
Device Sensing Problem 52 52
Kinked 52 52
Failure to Read Input Signal 51 51
Image Display Error/Artifact 50 50
Circuit Failure 49 49
Infusion or Flow Problem 49 49
Failure to Pump 47 47
Restricted Flow rate 47 47
Gas Output Problem 45 45
Disconnection 45 45
Temperature Problem 45 45
Material Puncture/Hole 43 43
Use of Device Problem 43 43
Crack 42 42
Protective Measures Problem 42 42
Device Markings/Labelling Problem 40 40
Computer Operating System Problem 40 40
Retraction Problem 39 39
No Device Output 37 37
Material Twisted/Bent 36 36
Insufficient Information 35 35
Migration 35 35
Audible Prompt/Feedback Problem 35 35
Device Emits Odor 35 35
Component Incompatible 35 35
No Audible Alarm 34 34
Device Packaging Compromised 34 34
Application Program Freezes, Becomes Nonfunctional 34 34
Material Integrity Problem 32 32
Migration or Expulsion of Device 31 31
Failure to Run on Battery 31 31
Incorrect Or Inadequate Test Results 29 29
Detachment of Device or Device Component 28 28

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7527 7527
No Patient Involvement 4420 4420
No Known Impact Or Consequence To Patient 4154 4154
No Consequences Or Impact To Patient 4076 4076
Insufficient Information 548 548
Death 383 383
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 141 141
Low Blood Pressure/ Hypotension 98 98
Injury 78 78
No Information 70 70
Cardiac Arrest 56 56
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 15 15
Failure of Implant 15 15
Ischemia 14 14
Nausea 14 14
Low Cardiac Output 14 14
Vascular Dissection 13 13
Abdominal Pain 12 12
Device Embedded In Tissue or Plaque 11 11
Arrhythmia 10 10
Atrial Fibrillation 10 10
Pain 10 10
Vessel Or Plaque, Device Embedded In 9 9
Loss of consciousness 9 9
Rupture 9 9
Cardiac Tamponade 8 8
Bradycardia 8 8
Cardiopulmonary Arrest 8 8
Stroke/CVA 8 8
Hematoma 8 8
Ventricular Fibrillation 8 8
High Blood Pressure/ Hypertension 7 7
Air Embolism 7 7
Venipuncture 7 7
Pseudoaneurysm 6 6
Diminished Pulse Pressure 6 6
Patient Problem/Medical Problem 6 6
Hypoxia 6 6
Fever 6 6
Heart Failure 6 6
Vomiting 6 6
Ventricular Tachycardia 5 5
Perforation of Vessels 5 5
Shock 5 5
Renal Failure 5 5
Foreign Body In Patient 5 5
Low Oxygen Saturation 5 5
Aortic Dissection 5 5
Chest Tightness/Pressure 4 4
Discomfort 4 4
Brain Injury 4 4
Vascular System (Circulation), Impaired 4 4
Thrombosis/Thrombus 4 4
Unspecified Vascular Problem 4 4
Pulmonary Edema 4 4
Pneumothorax 3 3
Weakness 3 3
Respiratory Distress 3 3
Perforation 3 3
Dyspnea 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
Tricuspid Valve Insufficiency/ Regurgitation 3 3
Test Result 3 3
Complaint, Ill-Defined 3 3
Obstruction/Occlusion 3 3
Confusion/ Disorientation 3 3
Loss Of Pulse 3 3
Respiratory Failure 2 2
Peritonitis 2 2
Numbness 2 2
Collapse 2 2
Stenosis 2 2
Convulsion/Seizure 2 2
Unspecified Kidney or Urinary Problem 2 2
Swelling/ Edema 2 2
Non specific EKG/ECG Changes 2 2
Aortic Valve Stenosis 2 2
Bone Fracture(s) 2 2
Extravasation 2 2
Congestive Heart Failure 2 2
Emotional Changes 2 2
Hemostasis 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
Transient Ischemic Attack 1 1
Renal Disease, End Stage 1 1
Skin Discoloration 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 Sep-08-2022
9 Datascope Corporation II Aug-21-2020
10 Datascope Corporation II Feb-02-2020
11 Datascope Corporation II Jul-12-2019
12 Datascope Corporation II Oct-11-2018
13 Datascope Corporation II Apr-16-2018
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
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