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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 2
ABIOMED INC.
  SUBSTANTIALLY EQUIVALENT 1
ABIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 3
ALSEAL
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, 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 4
CONTRACT MEDICAL INTL. GMBH
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 13
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 3
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
ENDOPHYS HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ENDOPHYS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 2
  SUBSTANTIALLY EQUIVALENT 5
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
ONSET MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT - KIT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
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
2015 912 912
2016 1233 1233
2017 1668 1668
2018 1899 1899
2019 2449 2449
2020 1449 1449

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1361 1361
Material Separation 1139 1139
Leak/Splash 893 893
Break 741 741
Fluid Leak 683 683
Detachment of Device or Device Component 644 644
Valve(s) 481 481
Material Deformation 313 313
Component Misassembled 287 287
Detachment Of Device Component 278 278
Difficult to Insert 226 226
Fracture 219 219
Difficult to Remove 213 213
Tip 211 211
Unraveled Material 185 185
Gas Leak 178 178
Difficult to Advance 167 167
Material Frayed 159 159
Flaked 134 134
Failure to Advance 134 134
Wire 132 132
Catheter 132 132
Device Contamination with Chemical or Other Material 131 131
Kinked 128 128
Insufficient Information 121 121
Material Split, Cut or Torn 118 118
Patient-Device Incompatibility 110 110
Guidewire 109 109
Physical Resistance/Sticking 97 97
Air Leak 94 94
Material Fragmentation 92 92
Device Operates Differently Than Expected 91 91
Use of Device Problem 84 84
Material Integrity Problem 83 83
Torn Material 77 77
Appropriate Term/Code Not Available 74 74
Material Puncture/Hole 72 72
Split 70 70
Crack 69 69
Physical Resistance 66 66
Hub 63 63
Contamination /Decontamination Problem 61 61
Separation Problem 59 59
Stretched 58 58
Backflow 53 53
Device Damaged Prior to Use 51 51
Connection Problem 51 51
Entrapment of Device 48 48
Bent 44 44
Material Twisted/Bent 43 43
Device Dislodged or Dislocated 39 39
Occlusion Within Device 39 39
Peeled/Delaminated 38 38
Defective Component 38 38
Improper or Incorrect Procedure or Method 38 38
Hemo Valve 35 35
Deformation Due to Compressive Stress 35 35
Activation, Positioning or SeparationProblem 30 30
Positioning Problem 30 30
Scratched Material 30 30
Sticking 28 28
Material Perforation 28 28
Partial Blockage 27 27
Needle 26 26
Device Markings/Labelling Problem 25 25
Device Contaminated During Manufacture or Shipping 24 24
Inadequacy of Device Shape and/or Size 23 23
Component Missing 21 21
Hole In Material 21 21
Migration or Expulsion of Device 21 21
Defective Device 20 20
Material Protrusion/Extrusion 19 19
Obstruction of Flow 18 18
Unsealed Device Packaging 17 17
Device Damaged by Another Device 17 17
Material Rupture 17 17
Loose or Intermittent Connection 17 17
Shaft 17 17
Fitting Problem 16 16
Mechanical Problem 16 16
Off-Label Use 16 16
Difficult To Position 14 14
Protective Measures Problem 14 14
Knotted 14 14
Dull, Blunt 13 13
Delivered as Unsterile Product 13 13
Disconnection 13 13
Patient Device Interaction Problem 13 13
Packaging Problem 13 13
Device Issue 13 13
Positioning Failure 13 13
Delamination 12 12
Device-Device Incompatibility 12 12
Manufacturing, Packaging or Shipping Problem 11 11
Tear, Rip or Hole in Device Packaging 11 11
Balloon 11 11
Difficult or Delayed Positioning 10 10
Wrinkled 10 10
Device Packaging Compromised 10 10
Human-Device Interface Problem 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3756 3756
No Known Impact Or Consequence To Patient 1809 1809
Blood Loss 839 839
No Code Available 483 483
No Patient Involvement 482 482
Cardiac Perforation 468 468
Device Embedded In Tissue or Plaque 343 343
Vascular Dissection 309 309
Death 214 214
Foreign Body In Patient 184 184
Hemorrhage/Bleeding 163 163
No Information 145 145
Hematoma 142 142
Perforation of Vessels 138 138
Low Blood Pressure/ Hypotension 83 83
Pericardial Effusion 78 78
Rupture 70 70
Air Embolism 66 66
Injury 61 61
Stroke/CVA 60 60
Aneurysm 60 60
Cardiac Tamponade 56 56
Perforation 54 54
Pain 48 48
Thrombus 45 45
Pseudoaneurysm 43 43
Thrombosis 40 40
Intimal Dissection 34 34
Tissue Damage 33 33
Cardiac Arrest 32 32
Fistula 32 32
Unspecified Infection 32 32
Aortic Dissection 26 26
Patient Problem/Medical Problem 24 24
Myocardial Infarction 22 22
Foreign body, removal of 22 22
Calcium Deposits/Calcification 22 22
Occlusion 21 21
Embolism 21 21
Anaphylactic Shock 21 21
Needle Stick/Puncture 21 21
Atrial Perforation 19 19
ST Segment Elevation 18 18
Vessel Or Plaque, Device Embedded In 17 17
Ischemia 17 17
Arrhythmia 16 16
Complete Heart Block 14 14
Extravasation 13 13
Edema 13 13
Hemostasis 13 13
Pneumothorax 13 13
Phlebitis 13 13
Reaction 13 13
Surgical procedure, additional 12 12
Cardiogenic Shock 12 12
Laceration(s) 12 12
Embolus 11 11
Stenosis 11 11
Bruise/Contusion 10 10
Chest Pain 10 10
Vascular System (Circulation), Impaired 10 10
Swelling 10 10
Transient Ischemic Attack 9 9
Bradycardia 9 9
Ventricular Fibrillation 9 9
Shock 9 9
Atrial Fibrillation 8 8
Fever 8 8
Pulmonary Embolism 7 7
Tachycardia 7 7
Paralysis 7 7
Dizziness 7 7
Great Vessel Perforation 6 6
Pleural Effusion 6 6
Post Operative Wound Infection 6 6
Cardiomyopathy 6 6
Exsanguination 6 6
Sepsis 6 6
Rash 6 6
Renal Failure 5 5
Cardiopulmonary Arrest 5 5
Erythema 5 5
Anemia 5 5
Claudication 5 5
Complaint, Ill-Defined 5 5
Respiratory Distress 5 5
Nerve Damage 5 5
Scar Tissue 4 4
Discomfort 4 4
Exposure to Body Fluids 4 4
Nausea 4 4
Hemothorax 4 4
Tissue Breakdown 4 4
Vaso-Vagal Response 4 4
Multiple Organ Failure 4 4
Respiratory Failure 4 4
Dyspnea 4 4
Non specific EKG/ECG Changes 4 4
High Blood Pressure/ Hypertension 4 4
Inflammation 4 4

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 Arrow International Inc II Jun-26-2015
19 BARD PERIPHERAL VASCULAR, INC I Jan-18-2017
20 Baylis Medical Company Inc. II May-21-2020
21 Boston Scientific Corporation I Dec-18-2015
22 Cook Inc. II Feb-20-2019
23 Cook Inc. II Mar-02-2017
24 Cook Inc. II Aug-22-2016
25 Cook Inc. II Feb-24-2016
26 Cook Inc. II Jul-18-2015
27 Creganna Medical Devices II Jun-14-2017
28 Galt Medical Corporation II Jul-27-2018
29 Greatbatch Medical II Jul-29-2017
30 Greatbatch Medical II Jul-29-2017
31 Greatbatch Medical II Nov-18-2016
32 Kalila Medical II Feb-09-2018
33 Medical Components, Inc dba MedComp II Jun-07-2016
34 Medtronic Inc. Cardiac Rhythm Disease Management I Mar-17-2015
35 Medtronic Vascular Galway DBA Medtronic Ireland I May-27-2020
36 Merit Medical Systems, Inc. II May-11-2020
37 Merit Medical Systems, Inc. II Feb-22-2018
38 Merit Medical Systems, Inc. I Mar-24-2017
39 Merit Medical Systems, Inc. II Jan-05-2017
40 Oscor, Inc. II Dec-19-2016
41 Sterilmed Inc I Dec-29-2017
42 Stryker Instruments Div. of Stryker Corporation II Dec-14-2015
43 Terumo Medical Corp II Dec-08-2017
44 Terumo Medical Corporation I May-28-2019
45 Terumo Medical Corporation II Feb-26-2018
46 Terumo Medical Corporation II May-04-2017
47 Terumo Medical Corporation II Sep-06-2016
48 W. L. Gore & Associates Inc. II May-11-2020
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