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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
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ABIOMED INC.
  SUBSTANTIALLY EQUIVALENT 2
ABIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 3
ACUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ALSEAL
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R.BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
CONTRACT MEDICAL INTERNATIONAL GMBH
  SUBSTANTIALLY EQUIVALENT 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 11
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EAST END MEDICAL I LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARD LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ENDOPHYS HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
ENDOPHYS HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ENDOPHYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPIEP, INC
  SUBSTANTIALLY EQUIVALENT 1
FREUDENBERG MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
FREUDENBERG MEDICAL MIS, 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
KEYSTONE HEART, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
LIBRA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP (MEDICAL COMPONENTS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC CRYOCATH LP
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 3
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
ONSET MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
RAM MEDICAL INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RHYTHM XIENCE, INC. (RXI)
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST JUDE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ST JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TALON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL COPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
TEXAS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSAORTIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRANSSEPTAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, 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 1900 1900
2019 2449 2449
2020 2465 2465
2021 2306 2306

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1722 1722
Adverse Event Without Identified Device or Use Problem 1525 1525
Fluid Leak 1098 1098
Detachment of Device or Device Component 990 990
Leak/Splash 863 863
Break 826 826
Material Deformation 510 510
Gas Leak 412 412
Difficult to Insert 294 294
Component Misassembled 287 287
Fracture 241 241
Unraveled Material 233 233
Difficult to Remove 225 225
Detachment Of Device Component 225 225
Difficult to Advance 191 191
Material Frayed 172 172
Material Split, Cut or Torn 165 165
Flaked 156 156
Failure to Advance 154 154
Physical Resistance/Sticking 140 140
Device Contamination with Chemical or Other Material 138 138
Patient-Device Incompatibility 138 138
Backflow 137 137
Kinked 117 117
Material Integrity Problem 114 114
Insufficient Information 109 109
Material Puncture/Hole 107 107
Use of Device Problem 107 107
Appropriate Term/Code Not Available 103 103
Material Fragmentation 96 96
Air Leak 89 89
Crack 86 86
Device Operates Differently Than Expected 85 85
Obstruction of Flow 82 82
Contamination /Decontamination Problem 78 78
Entrapment of Device 78 78
Stretched 75 75
Patient Device Interaction Problem 73 73
Split 66 66
Material Twisted/Bent 65 65
Connection Problem 61 61
Torn Material 60 60
Separation Problem 60 60
Improper or Incorrect Procedure or Method 58 58
Deformation Due to Compressive Stress 57 57
Device Damaged Prior to Use 54 54
Peeled/Delaminated 54 54
Physical Resistance 53 53
Defective Component 49 49
Device Dislodged or Dislocated 42 42
Activation, Positioning or SeparationProblem 40 40
Bent 35 35
Defective Device 34 34
Material Perforation 34 34
Partial Blockage 33 33
Occlusion Within Device 32 32
Positioning Problem 32 32
Device Contaminated During Manufacture or Shipping 31 31
Material Too Rigid or Stiff 31 31
Scratched Material 30 30
Packaging Problem 27 27
Material Protrusion/Extrusion 26 26
Component Missing 26 26
Device Damaged by Another Device 26 26
Device-Device Incompatibility 25 25
Device Markings/Labelling Problem 24 24
Unsealed Device Packaging 24 24
Sticking 23 23
Material Rupture 22 22
Migration or Expulsion of Device 21 21
Mechanical Problem 21 21
Loose or Intermittent Connection 20 20
Inadequacy of Device Shape and/or Size 20 20
Fitting Problem 17 17
Hole In Material 17 17
Off-Label Use 16 16
Delivered as Unsterile Product 15 15
Manufacturing, Packaging or Shipping Problem 15 15
Difficult or Delayed Separation 15 15
Protective Measures Problem 14 14
Migration 13 13
No Apparent Adverse Event 13 13
Nonstandard Device 13 13
Difficult or Delayed Positioning 13 13
Disconnection 12 12
Device Contamination with Body Fluid 12 12
Device Issue 12 12
Tear, Rip or Hole in Device Packaging 12 12
Incorrect, Inadequate or Imprecise Resultor Readings 11 11
Knotted 11 11
Device Packaging Compromised 10 10
Wrinkled 10 10
Sharp Edges 10 10
Device Handling Problem 10 10
Human-Device Interface Problem 10 10
Malposition of Device 9 9
Retraction Problem 9 9
Accessory Incompatible 9 9
Component Falling 8 8
Corroded 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4066 4066
No Clinical Signs, Symptoms or Conditions 2050 2050
No Known Impact Or Consequence To Patient 1631 1631
Blood Loss 784 784
Cardiac Perforation 509 509
No Patient Involvement 497 497
No Code Available 477 477
Vascular Dissection 381 381
Device Embedded In Tissue or Plaque 323 323
Foreign Body In Patient 252 252
Hemorrhage/Bleeding 204 204
Death 194 194
Hematoma 174 174
Perforation of Vessels 155 155
No Information 140 140
Pericardial Effusion 99 99
Insufficient Information 93 93
Cardiac Tamponade 82 82
Low Blood Pressure/ Hypotension 79 79
Stroke/CVA 77 77
Air Embolism 74 74
Aneurysm 70 70
Perforation 64 64
Rupture 57 57
Pseudoaneurysm 56 56
Pain 48 48
Injury 44 44
Thrombosis 39 39
Thrombus 37 37
Cardiac Arrest 37 37
Intimal Dissection 35 35
Fistula 33 33
Unspecified Infection 31 31
Myocardial Infarction 27 27
Tissue Damage 26 26
Embolism 24 24
Occlusion 23 23
Aortic Dissection 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Patient Problem/Medical Problem 22 22
Needle Stick/Puncture 21 21
Anaphylactic Shock 21 21
Calcium Deposits/Calcification 21 21
Arrhythmia 20 20
ST Segment Elevation 19 19
Cardiogenic Shock 18 18
Bruise/Contusion 17 17
Ischemia 17 17
Atrial Perforation 17 17
Vessel Or Plaque, Device Embedded In 16 16
Pneumothorax 16 16
Transient Ischemic Attack 15 15
Thrombosis/Thrombus 15 15
Reaction 14 14
Edema 13 13
Hemostasis 13 13
Embolism/Embolus 13 13
Foreign Body Embolism 12 12
Embolus 12 12
Extravasation 12 12
Laceration(s) 12 12
Ventricular Fibrillation 12 12
Phlebitis 12 12
Tachycardia 11 11
Stenosis 11 11
Bradycardia 11 11
Atrial Fibrillation 10 10
Swelling 10 10
Great Vessel Perforation 9 9
Chest Pain 9 9
Fever 8 8
Vascular System (Circulation), Impaired 8 8
Complete Heart Block 8 8
Exsanguination 7 7
Inflammation 7 7
Dizziness 7 7
Pleural Effusion 7 7
Paralysis 7 7
Shock 6 6
Sepsis 6 6
Loss of consciousness 6 6
Hemothorax 6 6
Non specific EKG/ECG Changes 6 6
Pulmonary Embolism 6 6
Multiple Organ Failure 6 6
Heart Block 6 6
Unspecified Tissue Injury 6 6
Cramp(s) /Muscle Spasm(s) 5 5
Thromboembolism 5 5
Claudication 5 5
Exposure to Body Fluids 5 5
Cardiomyopathy 5 5
Cardiopulmonary Arrest 5 5
Erythema 5 5
Hypersensitivity/Allergic reaction 5 5
Respiratory Distress 5 5
Nausea 5 5
Nerve Damage 5 5
Rash 5 5
Obstruction/Occlusion 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 Apr-21-2021
5 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
6 Angiodynamics, Inc. II Dec-16-2016
7 Angiodynamics, Inc. III Dec-16-2016
8 Argon Medical Devices, Inc II Sep-21-2021
9 Argon Medical Devices, Inc II Feb-05-2021
10 Argon Medical Devices, Inc II Oct-07-2016
11 Arrow International Inc II Feb-14-2020
12 Arrow International Inc II Sep-23-2019
13 Arrow International Inc II Jul-30-2018
14 Arrow International Inc II May-30-2018
15 Arrow International Inc II Apr-10-2018
16 Arrow International Inc II Apr-02-2018
17 Arrow International Inc II Mar-05-2018
18 Arrow International Inc II Jun-27-2017
19 Arrow International Inc II Jun-12-2017
20 Arrow International Inc II Mar-07-2016
21 BARD PERIPHERAL VASCULAR, INC I Jan-18-2017
22 Baylis Medical Company Inc. II May-21-2020
23 Biosense Webster, Inc. II Mar-22-2021
24 Cook Inc. II Oct-29-2021
25 Cook Inc. I Dec-23-2020
26 Cook Inc. II Feb-20-2019
27 Cook Inc. II Mar-02-2017
28 Cook Inc. II Aug-22-2016
29 Cook Inc. II Feb-24-2016
30 Creganna Medical Devices II Jun-14-2017
31 Galt Medical Corporation II Jul-27-2018
32 Greatbatch Medical II Jul-29-2017
33 Greatbatch Medical II Jul-29-2017
34 Greatbatch Medical II Nov-18-2016
35 Kalila Medical II Feb-09-2018
36 Medical Components, Inc dba MedComp II Jun-07-2016
37 Medtronic Vascular Galway DBA Medtronic Ireland I May-27-2020
38 Merit Medical Systems, Inc. II Aug-12-2021
39 Merit Medical Systems, Inc. II Aug-10-2021
40 Merit Medical Systems, Inc. II May-11-2020
41 Merit Medical Systems, Inc. II Feb-22-2018
42 Merit Medical Systems, Inc. I Mar-24-2017
43 Merit Medical Systems, Inc. II Jan-05-2017
44 Oscor, Inc. II Apr-01-2021
45 Oscor, Inc. II Dec-19-2016
46 Sterilmed Inc I Dec-29-2017
47 Terumo Medical Corp II Dec-08-2017
48 Terumo Medical Corporation I May-28-2019
49 Terumo Medical Corporation II Feb-26-2018
50 Terumo Medical Corporation II May-04-2017
51 Terumo Medical Corporation II Sep-06-2016
52 W. L. Gore & Associates Inc. II May-11-2020
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