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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device introducer, catheter
Product CodeDYB
Regulation Number 870.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ABIOMED INC.
  SUBSTANTIALLY EQUIVALENT 3
ABIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 2
ACUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 2
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BARD PERIPHERAL VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 5
BIOCARDIA, 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 1
CONTRACT MEDICAL INTERNATIONAL GMBH
  SUBSTANTIALLY EQUIVALENT 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 5
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CURATIA MEDICAL CO.
  SUBSTANTIALLY EQUIVALENT 1
DIB ULTRANAV MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EAST END MEDICAL I LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ENDOPHYS HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
ENDOPHYS HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
FREUDENBERG MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
FREUDENBERG MEDICAL MIS, INC
  SUBSTANTIALLY EQUIVALENT 1
GREATBATCH MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KEYSTONE HEART, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT - KIT 1
MERIT MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
RAM MEDICAL INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TALON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL COPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TRANSAORTIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSSEPTAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIZARAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1901 1901
2019 2449 2449
2020 2465 2465
2021 2835 3045
2022 4088 8476

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2368 2393
Adverse Event Without Identified Device or Use Problem 1768 3956
Fluid/Blood Leak 1666 1666
Detachment of Device or Device Component 1192 1192
Break 828 1038
Material Deformation 688 688
Gas/Air Leak 580 580
Leak/Splash 544 615
Material Split, Cut or Torn 356 356
Difficult to Insert 343 343
Component Misassembled 329 329
Device-Device Incompatibility 287 287
Unraveled Material 262 262
Obstruction of Flow 262 262
Difficult to Advance 243 243
Physical Resistance/Sticking 243 243
Fracture 223 223
Backflow 217 217
Material Puncture/Hole 212 212
Difficult to Remove 212 221
Failure to Advance 206 206
Flaked 190 190
Patient-Device Incompatibility 159 159
Material Frayed 157 157
Patient Device Interaction Problem 153 153
Contamination /Decontamination Problem 137 137
Peeled/Delaminated 136 136
Material Integrity Problem 134 134
Insufficient Information 132 2342
Appropriate Term/Code Not Available 128 128
Device Contamination with Chemical or Other Material 126 126
Material Twisted/Bent 119 119
Use of Device Problem 101 101
Entrapment of Device 81 81
Defective Component 75 90
Crack 69 69
Improper or Incorrect Procedure or Method 68 68
Deformation Due to Compressive Stress 67 67
Separation Problem 66 66
Stretched 60 60
Material Fragmentation 60 60
Detachment Of Device Component 60 60
Activation, Positioning or Separation Problem 58 58
Device Contaminated During Manufacture or Shipping 41 41
Air Leak 41 41
Material Too Rigid or Stiff 41 41
Connection Problem 39 39
Device Damaged Prior to Use 36 36
Defective Device 35 35
Material Perforation 33 33
Device Contamination with Body Fluid 30 30
Device Damaged by Another Device 30 30
Material Protrusion/Extrusion 29 29
Mechanical Problem 28 28
Air/Gas in Device 27 27
Packaging Problem 25 38
Partial Blockage 24 24
Kinked 23 23
Difficult or Delayed Separation 23 23
Positioning Problem 22 22
No Apparent Adverse Event 22 22
Component Missing 22 22
Device Dislodged or Dislocated 21 21
Torn Material 21 21
Scratched Material 19 19
Device Operates Differently Than Expected 19 19
Split 18 18
Unsealed Device Packaging 18 18
Device Markings/Labelling Problem 17 17
Inadequacy of Device Shape and/or Size 16 16
Material Rupture 16 16
Fitting Problem 15 15
Migration 15 15
Nonstandard Device 14 14
Delivered as Unsterile Product 13 13
Loose or Intermittent Connection 13 13
Corroded 13 13
Sharp Edges 13 13
Protective Measures Problem 13 13
Material Too Soft/Flexible 12 12
Incorrect, Inadequate or Imprecise Result or Readings 12 12
Off-Label Use 12 12
Malposition of Device 11 11
Manufacturing, Packaging or Shipping Problem 11 11
Contamination 11 11
Accessory Incompatible 11 11
Difficult or Delayed Positioning 11 11
Component Incompatible 10 10
Migration or Expulsion of Device 10 10
Tear, Rip or Hole in Device Packaging 10 10
Therapeutic or Diagnostic Output Failure 10 10
Output Problem 9 9
Mechanical Jam 9 9
Retraction Problem 9 9
Loss of or Failure to Bond 8 8
Physical Resistance 8 8
Separation Failure 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Bent 7 7
Complete Blockage 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5374 5374
No Consequences Or Impact To Patient 3212 3361
No Known Impact Or Consequence To Patient 824 824
Vascular Dissection 516 807
Blood Loss 434 439
Cardiac Perforation 433 433
No Patient Involvement 396 402
Hemorrhage/Bleeding 349 811
Foreign Body In Patient 346 346
Insufficient Information 321 363
No Code Available 313 313
Hematoma 188 630
Perforation of Vessels 176 176
Device Embedded In Tissue or Plaque 174 174
Death 126 126
Pericardial Effusion 105 105
Cardiac Tamponade 104 104
No Information 90 90
Air Embolism 83 83
Aneurysm 83 83
Pseudoaneurysm 81 81
Stroke/CVA 80 80
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 70 2351
Unspecified Vascular Problem 64 813
Perforation 63 63
Low Blood Pressure/ Hypotension 61 61
Bacterial Infection 55 79
Pain 54 54
Cardiac Arrest 46 46
Thrombosis/Thrombus 46 46
Unspecified Infection 43 61
Fistula 38 38
Rupture 36 36
Obstruction/Occlusion 33 33
Retroperitoneal Hemorrhage 31 225
Thrombosis 29 29
Arrhythmia 26 26
Intimal Dissection 24 24
Foreign Body Embolism 23 23
Myocardial Infarction 22 22
Great Vessel Perforation 21 21
Anaphylactic Shock 21 21
Unspecified Tissue Injury 21 21
Embolism/Embolus 21 21
Cardiogenic Shock 21 21
Embolism 20 20
Needle Stick/Puncture 20 20
Thrombus 20 20
Ischemia 19 19
Injury 18 18
Bruise/Contusion 18 48
Transient Ischemic Attack 16 16
Laceration(s) 16 16
Cramp(s) /Muscle Spasm(s) 16 16
Calcium Deposits/Calcification 15 15
Aortic Dissection 15 15
Occlusion 15 15
Thromboembolism 15 15
Heart Block 13 13
Reaction 12 12
Stenosis 11 11
Pneumothorax 11 11
Tachycardia 11 11
Ventricular Fibrillation 11 11
Vessel Or Plaque, Device Embedded In 11 11
Bradycardia 11 11
Atrial Perforation 11 11
Tissue Damage 10 10
ST Segment Elevation 9 9
Non specific EKG/ECG Changes 9 9
Paralysis 9 9
Pleural Effusion 8 8
Pulmonary Embolism 8 8
Edema 8 8
Patient Problem/Medical Problem 7 7
Swelling 7 7
Ischemic Heart Disease 7 7
Hypovolemia 7 7
Hemostasis 7 7
Embolus 7 7
Dizziness 7 7
Vasoconstriction 7 7
Sepsis 6 6
Heart Failure/Congestive Heart Failure 6 6
Nerve Damage 6 6
Chest Pain 6 6
Atrial Fibrillation 6 6
Exposure to Body Fluids 6 18
Hemothorax 6 6
Loss of consciousness 6 6
Inflammation 6 6
Complete Heart Block 5 5
Multiple Organ Failure 5 5
Swelling/ Edema 5 5
Erythema 5 5
Hypovolemic Shock 5 5
Cardiopulmonary Arrest 4 4
Extravasation 4 4
Vomiting 4 4
Discomfort 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Dec-27-2021
2 Abbott Medical II Jan-08-2020
3 Abbott Medical II Jan-07-2020
4 Acutus Medical Inc II Apr-23-2020
5 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-21-2021
6 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
7 Argon Medical Devices, Inc II Sep-21-2021
8 Argon Medical Devices, Inc II Feb-05-2021
9 Arrow International Inc II Feb-14-2020
10 Arrow International Inc II Sep-23-2019
11 Arrow International Inc II Jul-30-2018
12 Arrow International Inc II May-30-2018
13 Arrow International Inc II Apr-10-2018
14 Arrow International Inc II Apr-02-2018
15 Arrow International Inc II Mar-05-2018
16 Baylis Medical Company Inc. II May-21-2020
17 Biosense Webster, Inc. II Sep-02-2022
18 Biosense Webster, Inc. II Mar-22-2021
19 Cook Inc. II Dec-16-2021
20 Cook Inc. II Oct-29-2021
21 Cook Inc. I Dec-23-2020
22 Cook Inc. II Feb-20-2019
23 Freudenberg Medical, Llc II Apr-28-2022
24 Galt Medical Corporation II Jul-27-2018
25 Kalila Medical II Feb-09-2018
26 Medtronic Vascular Galway DBA Medtronic Ireland I May-27-2020
27 Merit Medical Systems, Inc. II Aug-12-2021
28 Merit Medical Systems, Inc. II Aug-10-2021
29 Merit Medical Systems, Inc. II May-11-2020
30 Merit Medical Systems, Inc. II Feb-22-2018
31 Oscor Inc. II Feb-17-2022
32 Oscor, Inc. II Apr-01-2021
33 Terumo Medical Corporation I May-28-2019
34 Terumo Medical Corporation II Feb-26-2018
35 W. L. Gore & Associates Inc. II May-11-2020
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