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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 4
ACUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
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 3
C.R.BARD, INC
  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 4
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
EAST END MEDICAL I, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
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 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
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TALON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIZARAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2465 2465
2021 2835 3045
2022 4084 8472
2023 3784 7892
2024 3932 7931
2025 1640 2616

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2817 2842
Fluid/Blood Leak 2510 2510
Adverse Event Without Identified Device or Use Problem 2500 9609
Detachment of Device or Device Component 1183 1183
Break 1064 1274
Gas/Air Leak 978 978
Material Deformation 944 944
Material Split, Cut or Torn 841 841
Backflow 596 596
Physical Resistance/Sticking 528 528
Patient Device Interaction Problem 501 501
Device-Device Incompatibility 469 469
Material Puncture/Hole 464 464
Difficult to Insert 464 464
Leak/Splash 438 509
Peeled/Delaminated 416 416
Difficult to Advance 383 383
Unraveled Material 347 347
Obstruction of Flow 309 309
Failure to Advance 305 305
Difficult to Remove 292 301
Insufficient Information 270 6642
Fracture 227 227
Material Twisted/Bent 223 223
Material Integrity Problem 221 221
Material Frayed 209 209
Flaked 202 202
Use of Device Problem 183 183
Appropriate Term/Code Not Available 175 175
Contamination /Decontamination Problem 169 169
Material Too Rigid or Stiff 144 144
Patient-Device Incompatibility 144 144
Defective Component 131 146
Device Contamination with Chemical or Other Material 121 121
Deformation Due to Compressive Stress 107 107
Improper or Incorrect Procedure or Method 87 87
Entrapment of Device 85 85
Defective Device 80 80
Activation, Positioning or Separation Problem 78 78
Mechanical Problem 74 74
Manufacturing, Packaging or Shipping Problem 61 61
Material Protrusion/Extrusion 60 60
Stretched 60 60
Positioning Problem 60 60
Separation Problem 59 59
Device Contaminated During Manufacture or Shipping 54 54
Crack 54 54
Component Misassembled 53 53
Air/Gas in Device 52 52
Partial Blockage 51 51

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11559 11559
No Consequences Or Impact To Patient 1343 1492
Vascular Dissection 941 1233
Hemorrhage/Bleeding 747 2158
Insufficient Information 663 705
Foreign Body In Patient 551 551
Cardiac Perforation 419 419
Hematoma 359 1557
Perforation of Vessels 358 358
Unspecified Vascular Problem 319 5117
Pericardial Effusion 289 289
Cardiac Tamponade 262 262
Low Blood Pressure/ Hypotension 215 215
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 154 5170
Thrombosis/Thrombus 148 148
Air Embolism 145 145
Blood Loss 140 145
Pseudoaneurysm 134 134
No Known Impact Or Consequence To Patient 134 134
Retroperitoneal Hemorrhage 113 901
Obstruction/Occlusion 102 102
No Patient Involvement 94 100
Cardiac Arrest 92 92
Stroke/CVA 87 87
Perforation 87 87
Device Embedded In Tissue or Plaque 79 79
No Code Available 79 79
Pain 76 76
Aneurysm 73 73
Unspecified Infection 63 81
Bacterial Infection 59 83
Embolism/Embolus 59 59
Arrhythmia 55 55
Rupture 55 55
Fistula 51 51
Thromboembolism 47 47
Unspecified Tissue Injury 45 45
Great Vessel Perforation 44 44
Death 44 44
Heart Block 36 36
Foreign Body Embolism 32 32
Stenosis 28 28
Cramp(s) /Muscle Spasm(s) 25 25
Pulmonary Embolism 25 25
Tachycardia 23 23
Cardiovascular Insufficiency 23 23
No Information 22 22
Ischemic Heart Disease 22 22
Bradycardia 20 20
Asystole 20 20

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 Baylis Medical Company Inc. II May-21-2020
12 Biosense Webster, Inc. II Sep-02-2022
13 Biosense Webster, Inc. II Mar-22-2021
14 Biosense Webster, Inc. II Mar-13-2024
15 Biosense Webster, Inc. II Apr-01-2023
16 Boston Scientific Corporation II Mar-28-2024
17 Cook Inc. II Dec-16-2021
18 Cook Inc. II Oct-29-2021
19 Cook Inc. I Dec-23-2020
20 Cook Incorporated II May-16-2025
21 Cook Incorporated II Oct-09-2024
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 May-07-2025
27 Galt Medical Corporation II Jun-15-2023
28 MEDLINE INDUSTRIES, LP - Northfield II Jan-29-2025
29 Medtronic Vascular Galway DBA Medtronic Ireland I May-27-2020
30 Merit Medical Systems, Inc. II Mar-24-2025
31 Merit Medical Systems, Inc. II Aug-12-2024
32 Merit Medical Systems, Inc. II Jun-27-2024
33 Merit Medical Systems, Inc. II May-20-2024
34 Merit Medical Systems, Inc. II May-10-2023
35 Merit Medical Systems, Inc. II Aug-12-2021
36 Merit Medical Systems, Inc. II Aug-10-2021
37 Merit Medical Systems, Inc. II May-11-2020
38 Oscor Inc. II Feb-17-2022
39 Oscor, Inc. II Apr-01-2021
40 St. Jude Medical II Jul-12-2024
41 W. L. Gore & Associates Inc. II May-11-2020
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