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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 2
ABIOMED INC.
  SUBSTANTIALLY EQUIVALENT 3
ABIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 3
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 6
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R.BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
CIRCA SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTRACT MEDICAL INTERNATIONAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
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
FREUDENBERG MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
FREUDENBERG MEDICAL MIS, INC
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
INNEUROCO INC.
  SUBSTANTIALLY EQUIVALENT 1
KEYSTONE HEART, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
RAM MEDICAL INNOVATIONS, INC.
  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 2
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TALON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL COPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRANSAORTIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIZARAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2449 2449
2020 2465 2465
2021 2835 3045
2022 4084 8472
2023 3783 7891
2024 1244 2230

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2701 2726
Adverse Event Without Identified Device or Use Problem 2285 7270
Fluid/Blood Leak 2163 2163
Detachment of Device or Device Component 1280 1280
Break 984 1194
Material Deformation 832 832
Gas/Air Leak 719 719
Material Split, Cut or Torn 596 596
Leak/Splash 513 584
Difficult to Insert 425 425
Device-Device Incompatibility 385 385
Physical Resistance/Sticking 385 385
Backflow 360 360
Difficult to Advance 344 344
Component Misassembled 333 333
Material Puncture/Hole 324 324
Unraveled Material 321 321
Patient Device Interaction Problem 314 314
Obstruction of Flow 303 303
Peeled/Delaminated 290 290
Difficult to Remove 264 273
Failure to Advance 259 259
Flaked 242 242
Insufficient Information 232 4739
Fracture 223 223
Contamination /Decontamination Problem 191 191
Material Frayed 187 187
Material Twisted/Bent 183 183
Material Integrity Problem 175 175
Use of Device Problem 153 153
Patient-Device Incompatibility 148 148
Appropriate Term/Code Not Available 148 148
Device Contamination with Chemical or Other Material 120 120
Defective Component 114 129
Deformation Due to Compressive Stress 97 97
Entrapment of Device 88 88
Improper or Incorrect Procedure or Method 83 83
Material Too Rigid or Stiff 80 80
Activation, Positioning or Separation Problem 74 74
Separation Problem 68 68
Stretched 66 66
Crack 64 64
Device Contaminated During Manufacture or Shipping 56 56
Mechanical Problem 52 52
Defective Device 48 48
Air/Gas in Device 48 48
Material Fragmentation 44 44
Positioning Problem 43 43
Manufacturing, Packaging or Shipping Problem 39 39
Device Contamination with Body Fluid 39 39
Material Protrusion/Extrusion 38 38
Partial Blockage 37 37
Material Perforation 36 36
Connection Problem 36 36
Device Damaged by Another Device 35 35
No Apparent Adverse Event 34 34
Device Dislodged or Dislocated 32 32
Packaging Problem 30 43
Device Damaged Prior to Use 28 28
Difficult or Delayed Separation 28 28
Component Missing 23 23
Mechanical Jam 22 22
Unsealed Device Packaging 21 21
Material Too Soft/Flexible 20 20
Inadequacy of Device Shape and/or Size 19 19
Coagulation in Device or Device Ingredient 19 19
Malposition of Device 19 19
Nonstandard Device 18 18
Delivered as Unsterile Product 18 18
Loose or Intermittent Connection 17 17
Fitting Problem 17 17
Unintended Movement 17 17
Component Incompatible 16 16
Contamination 16 16
Display or Visual Feedback Problem 16 16
Migration 16 16
Material Rupture 15 15
Tear, Rip or Hole in Device Packaging 15 15
Device Markings/Labelling Problem 14 14
Therapeutic or Diagnostic Output Failure 14 14
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Sharp Edges 14 14
Output Problem 12 12
Retraction Problem 11 11
Migration or Expulsion of Device 11 11
Corroded 11 11
Accessory Incompatible 11 11
Loss of or Failure to Bond 10 10
Difficult or Delayed Positioning 10 10
Off-Label Use 9 9
Complete Blockage 8 8
Infusion or Flow Problem 8 8
Device Misassembled During Manufacturing /Shipping 8 8
Communication or Transmission Problem 7 7
Structural Problem 7 7
Positioning Failure 6 6
Product Quality Problem 6 6
Device Handling Problem 6 6
Activation Problem 5 5
Device Difficult to Setup or Prepare 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8588 8588
No Consequences Or Impact To Patient 2458 2607
Vascular Dissection 781 1073
Insufficient Information 539 581
Hemorrhage/Bleeding 537 1553
Foreign Body In Patient 483 483
Cardiac Perforation 447 447
No Known Impact Or Consequence To Patient 392 392
No Patient Involvement 334 340
Blood Loss 317 322
Hematoma 284 1136
Perforation of Vessels 257 257
Pericardial Effusion 226 226
Cardiac Tamponade 220 220
No Code Available 206 206
Unspecified Vascular Problem 183 2309
Low Blood Pressure/ Hypotension 150 150
Device Embedded In Tissue or Plaque 132 132
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 131 4709
Air Embolism 115 115
Pseudoaneurysm 114 114
Thrombosis/Thrombus 96 96
Aneurysm 92 92
Stroke/CVA 92 92
Death 90 90
Perforation 87 87
Obstruction/Occlusion 85 85
Retroperitoneal Hemorrhage 82 731
Cardiac Arrest 76 76
No Information 69 69
Pain 65 65
Bacterial Infection 57 81
Unspecified Infection 53 71
Rupture 47 47
Fistula 46 46
Embolism/Embolus 37 37
Arrhythmia 35 35
Unspecified Tissue Injury 33 33
Thromboembolism 31 31
Stenosis 28 28
Great Vessel Perforation 26 26
Heart Block 26 26
Foreign Body Embolism 26 26
Thrombosis 25 25
Cramp(s) /Muscle Spasm(s) 22 22
Myocardial Infarction 21 21
Pulmonary Embolism 20 20
Bradycardia 20 20
Bruise/Contusion 20 50
Tachycardia 19 19
Ventricular Fibrillation 19 19
Cardiovascular Insufficiency 19 19
Transient Ischemic Attack 18 18
Embolism 18 18
Laceration(s) 17 17
Calcium Deposits/Calcification 17 17
Vasoconstriction 17 17
Cardiogenic Shock 17 17
Ischemic Heart Disease 17 17
Thrombus 15 15
Ischemia 15 15
Pneumothorax 14 14
Needle Stick/Puncture 14 14
Swelling/ Edema 14 14
Asystole 14 14
Non specific EKG/ECG Changes 13 13
Intimal Dissection 13 13
Chest Pain 12 12
Paralysis 12 12
Pleural Effusion 11 11
Injury 11 11
Pericarditis 11 11
Aortic Dissection 10 10
Nerve Damage 10 10
Dyspnea 10 10
Atrial Fibrillation 10 10
Hemothorax 10 10
Anemia 9 9
Occlusion 9 9
ST Segment Elevation 9 9
Tissue Damage 8 8
Vessel Or Plaque, Device Embedded In 8 8
Heart Failure/Congestive Heart Failure 8 8
Anaphylactic Shock 7 7
Exposure to Body Fluids 7 19
Edema 7 7
Inflammation 7 7
Dizziness 7 7
Discomfort 7 7
Hypovolemia 7 7
Loss of consciousness 6 6
Sepsis 6 6
Hemostasis 6 6
Hypovolemic Shock 6 6
Exsanguination 6 6
Diminished Pulse Pressure 6 6
Patient Problem/Medical Problem 5 5
Skin Inflammation/ Irritation 5 5
Ischemia Stroke 5 5
Extravasation 5 5

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 Abiomed, Inc. II Jan-05-2024
5 Abiomed, Inc. II Jul-11-2023
6 Acutus Medical Inc II Apr-23-2020
7 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-21-2021
8 Argon Medical Devices, Inc II Sep-21-2021
9 Argon Medical Devices, Inc II Feb-05-2021
10 Arrow International Inc II Feb-14-2020
11 Arrow International Inc II Sep-23-2019
12 Baylis Medical Company Inc. II May-21-2020
13 Biosense Webster, Inc. II Sep-02-2022
14 Biosense Webster, Inc. II Mar-22-2021
15 Biosense Webster, Inc. II Mar-13-2024
16 Biosense Webster, Inc. II Apr-01-2023
17 Boston Scientific Corporation II Mar-28-2024
18 Cook Inc. II Dec-16-2021
19 Cook Inc. II Oct-29-2021
20 Cook Inc. I Dec-23-2020
21 Cook Inc. II Feb-20-2019
22 Cook Incorporated II Apr-12-2024
23 Creganna Medical Devices II Jul-28-2023
24 Datascope Corp. II Jul-21-2023
25 Freudenberg Medical, Llc II Apr-28-2022
26 Galt Medical Corporation II Jun-15-2023
27 Medtronic Vascular Galway DBA Medtronic Ireland I May-27-2020
28 Merit Medical Systems, Inc. II May-20-2024
29 Merit Medical Systems, Inc. II May-10-2023
30 Merit Medical Systems, Inc. II Aug-12-2021
31 Merit Medical Systems, Inc. II Aug-10-2021
32 Merit Medical Systems, Inc. II May-11-2020
33 Oscor Inc. II Feb-17-2022
34 Oscor, Inc. II Apr-01-2021
35 Terumo Medical Corporation I May-28-2019
36 W. L. Gore & Associates Inc. II May-11-2020
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