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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 908 1894

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2669 2694
Adverse Event Without Identified Device or Use Problem 2248 7233
Fluid/Blood Leak 2102 2102
Detachment of Device or Device Component 1270 1270
Break 959 1169
Material Deformation 817 817
Gas/Air Leak 700 700
Material Split, Cut or Torn 581 581
Leak/Splash 505 576
Difficult to Insert 414 414
Physical Resistance/Sticking 375 375
Device-Device Incompatibility 375 375
Backflow 355 355
Difficult to Advance 335 335
Component Misassembled 333 333
Material Puncture/Hole 319 319
Unraveled Material 317 317
Obstruction of Flow 302 302
Patient Device Interaction Problem 295 295
Peeled/Delaminated 280 280
Difficult to Remove 258 267
Failure to Advance 254 254
Flaked 237 237
Insufficient Information 230 4737
Fracture 219 219
Contamination /Decontamination Problem 188 188
Material Frayed 187 187
Material Twisted/Bent 179 179
Material Integrity Problem 165 165
Patient-Device Incompatibility 148 148
Use of Device Problem 147 147
Appropriate Term/Code Not Available 143 143
Device Contamination with Chemical or Other Material 119 119
Defective Component 111 126
Deformation Due to Compressive Stress 94 94
Entrapment of Device 86 86
Improper or Incorrect Procedure or Method 82 82
Activation, Positioning or Separation Problem 74 74
Separation Problem 68 68
Material Too Rigid or Stiff 68 68
Stretched 66 66
Crack 64 64
Device Contaminated During Manufacture or Shipping 56 56
Mechanical Problem 50 50
Air/Gas in Device 48 48
Defective Device 47 47
Material Fragmentation 44 44
Positioning Problem 42 42
Device Contamination with Body Fluid 38 38
Manufacturing, Packaging or Shipping Problem 37 37
Material Protrusion/Extrusion 36 36
Partial Blockage 36 36
Device Damaged by Another Device 35 35
Material Perforation 35 35
Connection Problem 35 35
No Apparent Adverse Event 33 33
Device Dislodged or Dislocated 31 31
Packaging Problem 30 43
Difficult or Delayed Separation 28 28
Device Damaged Prior to Use 27 27
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
Malposition of Device 18 18
Delivered as Unsterile Product 18 18
Coagulation in Device or Device Ingredient 18 18
Loose or Intermittent Connection 17 17
Nonstandard Device 17 17
Unintended Movement 17 17
Fitting Problem 17 17
Component Incompatible 16 16
Display or Visual Feedback Problem 16 16
Contamination 16 16
Migration 16 16
Tear, Rip or Hole in Device Packaging 15 15
Material Rupture 15 15
Device Markings/Labelling Problem 14 14
Sharp Edges 14 14
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Therapeutic or Diagnostic Output Failure 14 14
Output Problem 12 12
Accessory Incompatible 11 11
Retraction Problem 11 11
Corroded 11 11
Migration or Expulsion of Device 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
Device Misassembled During Manufacturing /Shipping 8 8
Infusion or Flow Problem 8 8
Communication or Transmission Problem 7 7
Structural Problem 7 7
Product Quality Problem 6 6
Positioning Failure 6 6
Device Handling Problem 6 6
Use of Incorrect Control/Treatment Settings 5 5
Protective Measures Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8347 8347
No Consequences Or Impact To Patient 2458 2607
Vascular Dissection 757 1049
Insufficient Information 531 573
Hemorrhage/Bleeding 522 1538
Foreign Body In Patient 470 470
Cardiac Perforation 442 442
No Known Impact Or Consequence To Patient 392 392
No Patient Involvement 334 340
Blood Loss 317 322
Hematoma 275 1127
Perforation of Vessels 245 245
Pericardial Effusion 220 220
Cardiac Tamponade 214 214
No Code Available 206 206
Unspecified Vascular Problem 179 2305
Low Blood Pressure/ Hypotension 145 145
Device Embedded In Tissue or Plaque 132 132
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 130 4708
Air Embolism 112 112
Pseudoaneurysm 110 110
Stroke/CVA 92 92
Thrombosis/Thrombus 91 91
Death 90 90
Aneurysm 90 90
Perforation 87 87
Obstruction/Occlusion 82 82
Retroperitoneal Hemorrhage 81 730
Cardiac Arrest 74 74
No Information 69 69
Pain 61 61
Bacterial Infection 57 81
Unspecified Infection 53 71
Rupture 46 46
Fistula 42 42
Embolism/Embolus 34 34
Arrhythmia 33 33
Unspecified Tissue Injury 32 32
Thromboembolism 29 29
Foreign Body Embolism 26 26
Great Vessel Perforation 26 26
Thrombosis 25 25
Stenosis 25 25
Heart Block 25 25
Cramp(s) /Muscle Spasm(s) 22 22
Myocardial Infarction 21 21
Bradycardia 20 20
Bruise/Contusion 20 50
Ventricular Fibrillation 19 19
Tachycardia 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
Pulmonary Embolism 16 16
Thrombus 15 15
Cardiovascular Insufficiency 15 15
Asystole 14 14
Swelling/ Edema 14 14
Pneumothorax 14 14
Needle Stick/Puncture 14 14
Ischemia 14 14
Intimal Dissection 13 13
Non specific EKG/ECG Changes 13 13
Chest Pain 12 12
Paralysis 12 12
Pleural Effusion 11 11
Injury 11 11
Nerve Damage 10 10
Dyspnea 10 10
Atrial Fibrillation 10 10
Hemothorax 10 10
Aortic Dissection 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
Pericarditis 7 7
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
Extravasation 5 5
High Blood Pressure/ Hypertension 5 5
Hemoptysis 5 5
Shock 5 5
Coma 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-10-2023
29 Merit Medical Systems, Inc. II Aug-12-2021
30 Merit Medical Systems, Inc. II Aug-10-2021
31 Merit Medical Systems, Inc. II May-11-2020
32 Oscor Inc. II Feb-17-2022
33 Oscor, Inc. II Apr-01-2021
34 Terumo Medical Corporation I May-28-2019
35 W. L. Gore & Associates Inc. II May-11-2020
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