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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 2
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 985 1961

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2789 2814
Adverse Event Without Identified Device or Use Problem 2432 9541
Fluid/Blood Leak 2413 2413
Detachment of Device or Device Component 1159 1159
Break 1016 1226
Material Deformation 921 921
Gas/Air Leak 903 903
Material Split, Cut or Torn 781 781
Backflow 572 572
Physical Resistance/Sticking 508 508
Patient Device Interaction Problem 471 471
Device-Device Incompatibility 458 458
Material Puncture/Hole 439 439
Difficult to Insert 436 436
Leak/Splash 431 502
Peeled/Delaminated 400 400
Difficult to Advance 368 368
Unraveled Material 337 337
Obstruction of Flow 306 306
Failure to Advance 291 291
Difficult to Remove 280 289
Insufficient Information 268 6640
Fracture 222 222
Material Twisted/Bent 211 211
Material Frayed 207 207
Material Integrity Problem 206 206
Flaked 197 197
Appropriate Term/Code Not Available 168 168
Use of Device Problem 165 165
Contamination /Decontamination Problem 165 165
Patient-Device Incompatibility 139 139
Material Too Rigid or Stiff 137 137
Defective Component 125 140
Device Contamination with Chemical or Other Material 120 120
Deformation Due to Compressive Stress 105 105
Improper or Incorrect Procedure or Method 85 85
Entrapment of Device 83 83
Activation, Positioning or Separation Problem 77 77
Mechanical Problem 67 67
Defective Device 63 63
Stretched 60 60
Separation Problem 59 59
Manufacturing, Packaging or Shipping Problem 59 59
Positioning Problem 58 58
Material Protrusion/Extrusion 56 56
Device Contaminated During Manufacture or Shipping 54 54
Component Misassembled 53 53
Crack 52 52
Air/Gas in Device 50 50
Partial Blockage 49 49

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11086 11086
No Consequences Or Impact To Patient 1343 1492
Vascular Dissection 905 1197
Hemorrhage/Bleeding 708 2119
Insufficient Information 632 674
Foreign Body In Patient 531 531
Cardiac Perforation 405 405
Hematoma 344 1542
Perforation of Vessels 338 338
Unspecified Vascular Problem 317 5115
Pericardial Effusion 280 280
Cardiac Tamponade 251 251
Low Blood Pressure/ Hypotension 205 205
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 151 5167
Air Embolism 142 142
Blood Loss 140 145
Thrombosis/Thrombus 137 137
No Known Impact Or Consequence To Patient 134 134
Pseudoaneurysm 131 131
Retroperitoneal Hemorrhage 113 901
Obstruction/Occlusion 101 101
No Patient Involvement 94 100
Stroke/CVA 86 86
Perforation 85 85
Cardiac Arrest 85 85
No Code Available 79 79
Device Embedded In Tissue or Plaque 76 76
Pain 75 75
Aneurysm 71 71
Unspecified Infection 60 78
Bacterial Infection 58 82
Embolism/Embolus 58 58
Rupture 54 54
Arrhythmia 50 50
Fistula 48 48
Death 44 44
Great Vessel Perforation 43 43
Thromboembolism 43 43
Unspecified Tissue Injury 42 42
Heart Block 35 35
Foreign Body Embolism 31 31
Stenosis 27 27
Cramp(s) /Muscle Spasm(s) 24 24
Tachycardia 23 23
No Information 22 22
Ischemic Heart Disease 22 22
Bradycardia 20 20
Pulmonary Embolism 20 20
Asystole 19 19
Bruise/Contusion 19 49

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 Oct-09-2024
21 Cook Incorporated II Apr-12-2024
22 Creganna Medical Devices II Jul-28-2023
23 Datascope Corp. II Jul-21-2023
24 Freudenberg Medical, Llc II Apr-28-2022
25 Galt Medical Corporation II Jun-15-2023
26 MEDLINE INDUSTRIES, LP - Northfield II Jan-29-2025
27 Medtronic Vascular Galway DBA Medtronic Ireland I May-27-2020
28 Merit Medical Systems, Inc. II Mar-24-2025
29 Merit Medical Systems, Inc. II Aug-12-2024
30 Merit Medical Systems, Inc. II Jun-27-2024
31 Merit Medical Systems, Inc. II May-20-2024
32 Merit Medical Systems, Inc. II May-10-2023
33 Merit Medical Systems, Inc. II Aug-12-2021
34 Merit Medical Systems, Inc. II Aug-10-2021
35 Merit Medical Systems, Inc. II May-11-2020
36 Oscor Inc. II Feb-17-2022
37 Oscor, Inc. II Apr-01-2021
38 St. Jude Medical II Jul-12-2024
39 W. L. Gore & Associates Inc. II May-11-2020
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