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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 4
ABIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 3
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 4
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 3
BEIJING DEMAX MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOCYCLE MEDICAL(SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVIA , LTD.
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
CIRCA SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONTRACT MEDICAL INTERNATIONAL, GMBH
  SUBSTANTIALLY EQUIVALENT 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK, MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CORDIS US CORP
  SUBSTANTIALLY EQUIVALENT 1
CULTIV8 1, LLC
  SUBSTANTIALLY EQUIVALENT 1
CURATIA MEDICAL CO.
  SUBSTANTIALLY EQUIVALENT 1
DIB ULTRANAV MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EAST END MEDICAL I, LLC
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
INNEUROCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
JUPITER ENDOVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PULNOVO MEDICAL (WUXI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SONOSTIK, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOUTH53, LLC
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS,INC.
  SUBSTANTIALLY EQUIVALENT 2
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TALON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIVASURE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VIZARAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2835 3054
2022 4084 8487
2023 3775 7899
2024 3931 7936
2025 4593 8591
2026 424 424

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2887 2887
Material Separation 2695 2722
Adverse Event Without Identified Device or Use Problem 2619 11269
Gas/Air Leak 1284 1285
Material Split, Cut or Torn 1134 1137
Break 1108 1320
Detachment of Device or Device Component 898 898
Material Deformation 874 879
Backflow 656 656
Patient Device Interaction Problem 633 634
Physical Resistance/Sticking 606 607
Material Puncture/Hole 573 573
Device-Device Incompatibility 514 514
Peeled/Delaminated 484 486
Difficult to Insert 479 480
Difficult to Advance 429 434
Leak/Splash 374 446
Failure to Advance 331 331
Unraveled Material 328 329
Obstruction of Flow 312 312
Insufficient Information 300 8169
Difficult to Remove 296 307
Material Integrity Problem 271 271
Material Twisted/Bent 233 233
Fracture 229 230
Use of Device Problem 205 205
Flaked 205 205
Material Frayed 203 203
Appropriate Term/Code Not Available 172 172
Contamination /Decontamination Problem 170 170
Material Too Rigid or Stiff 147 147
Deformation Due to Compressive Stress 146 148
Defective Component 130 146
Patient-Device Incompatibility 125 126
Improper or Incorrect Procedure or Method 102 102
Defective Device 90 91
Mechanical Problem 89 89
Material Protrusion/Extrusion 79 79
Activation, Positioning or Separation Problem 79 79
Entrapment of Device 76 76
Positioning Problem 73 74
Manufacturing, Packaging or Shipping Problem 72 72
Air/Gas in Device 63 63
Crack 60 61
Component Misassembled 56 56
Partial Blockage 56 56
No Apparent Adverse Event 55 55
Stretched 51 51
Device Contaminated During Manufacture or Shipping 49 49
Device Contamination with Body Fluid 45 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13573 13590
Vascular Dissection 1018 1317
Hemorrhage/Bleeding 887 2593
Insufficient Information 733 779
Foreign Body In Patient 588 591
Perforation of Vessels 404 405
Unspecified Vascular Problem 398 7547
Hematoma 397 1883
Cardiac Perforation 363 364
Pericardial Effusion 328 333
Cardiac Tamponade 290 292
Low Blood Pressure/ Hypotension 256 258
Thrombosis/Thrombus 177 177
Air Embolism 159 160
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 157 5173
Pseudoaneurysm 144 144
Retroperitoneal Hemorrhage 130 1008
Obstruction/Occlusion 109 109
Cardiac Arrest 107 107
No Consequences Or Impact To Patient 96 245
Arrhythmia 95 95
Perforation 85 87
Pain 85 86
Embolism/Embolus 79 80
Stroke/CVA 78 78
Rupture 67 67
Unspecified Infection 64 82
Bacterial Infection 59 83
Fistula 59 59
Aneurysm 58 60
Thromboembolism 55 55
Device Embedded In Tissue or Plaque 48 50
Great Vessel Perforation 47 47
Unspecified Tissue Injury 46 47
Ischemia 44 44
Heart Block 37 37
Foreign Body Embolism 36 36
Stenosis 30 30
Tachycardia 28 28
Cramp(s) /Muscle Spasm(s) 27 27
Pulmonary Embolism 27 27
Ischemic Heart Disease 24 24
Cardiovascular Insufficiency 24 24
Asystole 23 24
Bradycardia 23 23
Swelling/ Edema 22 22
Non specific EKG/ECG Changes 21 21
Pericarditis 21 21
Ventricular Fibrillation 21 21
Chest Pain 19 19

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Dec-27-2021
2 Abiomed, Inc. II Jan-05-2024
3 Abiomed, Inc. II Jul-11-2023
4 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-21-2021
5 Argon Medical Devices, Inc II Sep-21-2021
6 Argon Medical Devices, Inc II Feb-05-2021
7 Biosense Webster, Inc. II Sep-02-2022
8 Biosense Webster, Inc. II Mar-22-2021
9 Biosense Webster, Inc. II Mar-13-2024
10 Biosense Webster, Inc. II Apr-01-2023
11 Boston Scientific Corporation II Mar-28-2024
12 Contract Medical International GmbH II Sep-05-2025
13 Cook Inc. II Dec-16-2021
14 Cook Inc. II Oct-29-2021
15 Cook Incorporated II Dec-23-2025
16 Cook Incorporated II May-16-2025
17 Cook Incorporated II Oct-09-2024
18 Cook Incorporated II Apr-12-2024
19 Creganna Medical Devices II Jul-28-2023
20 Datascope Corp. II Jul-21-2023
21 Freudenberg Medical, Llc II Apr-28-2022
22 Galt Medical Corporation II May-07-2025
23 Galt Medical Corporation II Jun-15-2023
24 MEDLINE INDUSTRIES, LP - Northfield II Jan-29-2025
25 Merit Medical Systems, Inc. II Mar-24-2025
26 Merit Medical Systems, Inc. II Aug-12-2024
27 Merit Medical Systems, Inc. II Jun-27-2024
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 Oscor Inc. II Feb-17-2022
33 Oscor, Inc. II Apr-01-2021
34 St. Jude Medical II Jul-12-2024
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