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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device introducer, catheter
Regulation Description Catheter introducer.
Product CodeDYB
Regulation Number 870.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
ABIOMED
  SUBSTANTIALLY EQUIVALENT 3
ABIOMED INC.
  SUBSTANTIALLY EQUIVALENT 2
ABIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 3
ALSEAL
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARGON MEDICAL DEVICES INC.
  SUBSTANTIALLY EQUIVALENT 2
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONTRACT MEDICAL INTL. GMBH
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 10
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
ENDOPHYS HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ENDOPHYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
GREATBATCH MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KALILA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDCOMP (MEDICAL COMPONENTS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 2
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
ONSET MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 5
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
THERAGENICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1233 1233
2017 1668 1668
2018 1899 1899
2019 2449 2449
2020 2465 2465

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1319 1319
Material Separation 1182 1182
Detachment of Device or Device Component 817 817
Leak/Splash 793 793
Fluid Leak 750 750
Break 706 706
Valve(s) 419 419
Material Deformation 374 374
Component Misassembled 287 287
Difficult to Insert 229 229
Detachment Of Device Component 225 225
Gas Leak 225 225
Fracture 201 201
Difficult to Remove 198 198
Unraveled Material 190 190
Tip 176 176
Difficult to Advance 162 162
Material Frayed 149 149
Flaked 142 142
Failure to Advance 136 136
Material Split, Cut or Torn 131 131
Device Contamination with Chemical or Other Material 129 129
Wire 123 123
Patient-Device Incompatibility 122 122
Kinked 117 117
Physical Resistance/Sticking 117 117
Catheter 101 101
Insufficient Information 97 97
Use of Device Problem 93 93
Guidewire 91 91
Material Puncture/Hole 89 89
Air Leak 89 89
Material Fragmentation 87 87
Device Operates Differently Than Expected 85 85
Material Integrity Problem 83 83
Appropriate Term/Code Not Available 78 78
Crack 70 70
Backflow 69 69
Split 66 66
Stretched 64 64
Contamination /Decontamination Problem 64 64
Separation Problem 60 60
Torn Material 60 60
Physical Resistance 53 53
Entrapment of Device 53 53
Connection Problem 52 52
Device Damaged Prior to Use 51 51
Hub 51 51
Material Twisted/Bent 49 49
Peeled/Delaminated 48 48
Improper or Incorrect Procedure or Method 40 40
Device Dislodged or Dislocated 40 40
Deformation Due to Compressive Stress 39 39
Bent 35 35
Defective Component 35 35
Hemo Valve 33 33
Occlusion Within Device 32 32
Partial Blockage 32 32
Activation, Positioning or SeparationProblem 31 31
Scratched Material 30 30
Positioning Problem 28 28
Material Perforation 28 28
Device Contaminated During Manufacture or Shipping 27 27
Component Missing 24 24
Defective Device 24 24
Sticking 23 23
Device Markings/Labelling Problem 22 22
Needle 22 22
Patient Device Interaction Problem 22 22
Obstruction of Flow 20 20
Migration or Expulsion of Device 20 20
Inadequacy of Device Shape and/or Size 20 20
Material Rupture 19 19
Unsealed Device Packaging 19 19
Device Damaged by Another Device 18 18
Material Protrusion/Extrusion 18 18
Hole In Material 17 17
Off-Label Use 16 16
Mechanical Problem 16 16
Protective Measures Problem 14 14
Loose or Intermittent Connection 14 14
Delivered as Unsterile Product 13 13
Fitting Problem 13 13
Manufacturing, Packaging or Shipping Problem 13 13
Device-Device Incompatibility 12 12
Tear, Rip or Hole in Device Packaging 12 12
Difficult or Delayed Positioning 12 12
Device Issue 12 12
Packaging Problem 11 11
Disconnection 11 11
Knotted 11 11
Shaft 10 10
Migration 10 10
Device Packaging Compromised 10 10
Wrinkled 10 10
Human-Device Interface Problem 9 9
Material Too Rigid or Stiff 9 9
Sharp Edges 9 9
Balloon 9 9
Accessory Incompatible 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3969 3969
No Known Impact Or Consequence To Patient 1623 1623
Blood Loss 782 782
No Patient Involvement 485 485
No Code Available 466 466
Cardiac Perforation 450 450
Device Embedded In Tissue or Plaque 309 309
Vascular Dissection 304 304
No Clinical Signs, Symptoms or Conditions 273 273
Death 194 194
Foreign Body In Patient 177 177
Hemorrhage/Bleeding 161 161
Hematoma 146 146
Perforation of Vessels 138 138
No Information 136 136
Pericardial Effusion 71 71
Low Blood Pressure/ Hypotension 69 69
Aneurysm 64 64
Stroke/CVA 63 63
Air Embolism 59 59
Cardiac Tamponade 57 57
Perforation 52 52
Rupture 49 49
Pseudoaneurysm 44 44
Injury 44 44
Pain 40 40
Thrombosis 39 39
Thrombus 37 37
Intimal Dissection 34 34
Insufficient Information 28 28
Cardiac Arrest 27 27
Fistula 27 27
Unspecified Infection 26 26
Tissue Damage 26 26
Myocardial Infarction 25 25
Embolism 24 24
Occlusion 23 23
Aortic Dissection 23 23
Patient Problem/Medical Problem 22 22
Calcium Deposits/Calcification 21 21
Needle Stick/Puncture 20 20
Anaphylactic Shock 20 20
ST Segment Elevation 19 19
Ischemia 17 17
Atrial Perforation 17 17
Vessel Or Plaque, Device Embedded In 16 16
Arrhythmia 16 16
Pneumothorax 16 16
Cardiogenic Shock 15 15
Reaction 14 14
Edema 13 13
Hemostasis 13 13
Embolus 12 12
Phlebitis 12 12
Extravasation 12 12
Transient Ischemic Attack 11 11
Laceration(s) 11 11
Stenosis 10 10
Swelling 10 10
Ventricular Fibrillation 9 9
Chest Pain 8 8
Atrial Fibrillation 8 8
Bradycardia 8 8
Bruise/Contusion 8 8
Vascular System (Circulation), Impaired 8 8
Fever 8 8
Complete Heart Block 8 8
Tachycardia 7 7
Dizziness 7 7
Pleural Effusion 6 6
Shock 6 6
Paralysis 6 6
Inflammation 6 6
Pulmonary Embolism 6 6
Exsanguination 6 6
Sepsis 6 6
Rash 5 5
Cardiomyopathy 5 5
Cardiopulmonary Arrest 5 5
Claudication 5 5
Multiple Organ Failure 5 5
Nerve Damage 5 5
Respiratory Distress 5 5
Great Vessel Perforation 5 5
Discomfort 4 4
Hemothorax 4 4
Nausea 4 4
Tissue Breakdown 4 4
Non specific EKG/ECG Changes 4 4
Erythema 4 4
Muscle Spasm(s) 4 4
Hypovolemic Shock 4 4
Hypersensitivity/Allergic reaction 3 3
Aspiration/Inhalation 3 3
Dyspnea 3 3
Anemia 3 3
Renal Failure 3 3
Ventricular Tachycardia 3 3
Respiratory Failure 3 3
Loss of consciousness 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Jan-08-2020
2 Abbott Medical II Jan-07-2020
3 Acutus Medical Inc II Apr-23-2020
4 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
5 Angiodynamics, Inc. II Dec-16-2016
6 Angiodynamics, Inc. III Dec-16-2016
7 Argon Medical Devices, Inc II Oct-07-2016
8 Arrow International Inc II Feb-14-2020
9 Arrow International Inc II Sep-23-2019
10 Arrow International Inc II Jul-30-2018
11 Arrow International Inc II May-30-2018
12 Arrow International Inc II Apr-10-2018
13 Arrow International Inc II Apr-02-2018
14 Arrow International Inc II Mar-05-2018
15 Arrow International Inc II Jun-27-2017
16 Arrow International Inc II Jun-12-2017
17 Arrow International Inc II Mar-07-2016
18 BARD PERIPHERAL VASCULAR, INC I Jan-18-2017
19 Baylis Medical Company Inc. II May-21-2020
20 Cook Inc. I Dec-23-2020
21 Cook Inc. II Feb-20-2019
22 Cook Inc. II Mar-02-2017
23 Cook Inc. II Aug-22-2016
24 Cook Inc. II Feb-24-2016
25 Creganna Medical Devices II Jun-14-2017
26 Galt Medical Corporation II Jul-27-2018
27 Greatbatch Medical II Jul-29-2017
28 Greatbatch Medical II Jul-29-2017
29 Greatbatch Medical II Nov-18-2016
30 Kalila Medical II Feb-09-2018
31 Medical Components, Inc dba MedComp II Jun-07-2016
32 Medtronic Vascular Galway DBA Medtronic Ireland I May-27-2020
33 Merit Medical Systems, Inc. II May-11-2020
34 Merit Medical Systems, Inc. II Feb-22-2018
35 Merit Medical Systems, Inc. I Mar-24-2017
36 Merit Medical Systems, Inc. II Jan-05-2017
37 Oscor, Inc. II Dec-19-2016
38 Sterilmed Inc I Dec-29-2017
39 Terumo Medical Corp II Dec-08-2017
40 Terumo Medical Corporation I May-28-2019
41 Terumo Medical Corporation II Feb-26-2018
42 Terumo Medical Corporation II May-04-2017
43 Terumo Medical Corporation II Sep-06-2016
44 W. L. Gore & Associates Inc. II May-11-2020
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