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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 3
ABIOMED INC.
  SUBSTANTIALLY EQUIVALENT 4
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 4
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 2
BIOCARDIA
  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 3
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 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 3784 7892
2024 2637 5586

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2834 2859
Adverse Event Without Identified Device or Use Problem 2480 8499
Fluid/Blood Leak 2354 2354
Detachment of Device or Device Component 1334 1334
Break 1063 1273
Material Deformation 916 916
Gas/Air Leak 786 786
Material Split, Cut or Torn 671 671
Leak/Splash 537 608
Physical Resistance/Sticking 452 452
Difficult to Insert 449 449
Device-Device Incompatibility 408 408
Material Puncture/Hole 392 392
Backflow 388 388
Patient Device Interaction Problem 377 377
Difficult to Advance 368 368
Unraveled Material 347 347
Component Misassembled 340 340
Peeled/Delaminated 333 333
Obstruction of Flow 310 310
Difficult to Remove 285 294
Failure to Advance 279 279
Insufficient Information 264 5700
Flaked 246 246
Fracture 244 244
Contamination /Decontamination Problem 205 205
Material Frayed 205 205
Material Twisted/Bent 203 203
Material Integrity Problem 197 197
Use of Device Problem 170 170
Appropriate Term/Code Not Available 156 156
Patient-Device Incompatibility 152 152
Device Contamination with Chemical or Other Material 122 122
Defective Component 122 137
Deformation Due to Compressive Stress 102 102
Material Too Rigid or Stiff 102 102
Entrapment of Device 94 94
Improper or Incorrect Procedure or Method 85 85
Activation, Positioning or Separation Problem 81 81
Separation Problem 69 69
Stretched 69 69
Crack 67 67
Device Contaminated During Manufacture or Shipping 62 62
Mechanical Problem 56 56
Defective Device 55 55
Air/Gas in Device 49 49
Positioning Problem 48 48
Manufacturing, Packaging or Shipping Problem 45 45
Material Fragmentation 44 44
Partial Blockage 44 44

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9490 9490
No Consequences Or Impact To Patient 2458 2607
Vascular Dissection 867 1159
Hemorrhage/Bleeding 609 1804
Insufficient Information 582 624
Foreign Body In Patient 517 517
Cardiac Perforation 484 484
No Known Impact Or Consequence To Patient 392 392
No Patient Involvement 334 340
Blood Loss 317 322
Hematoma 315 1338
Perforation of Vessels 306 306
Pericardial Effusion 253 253
Cardiac Tamponade 243 243
Unspecified Vascular Problem 239 3465
No Code Available 206 206
Low Blood Pressure/ Hypotension 169 169
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 148 5164
Device Embedded In Tissue or Plaque 134 134
Air Embolism 123 123
Pseudoaneurysm 121 121
Thrombosis/Thrombus 106 106
Retroperitoneal Hemorrhage 99 824
Stroke/CVA 96 96
Perforation 92 92
Obstruction/Occlusion 92 92
Aneurysm 92 92
Death 90 90
Cardiac Arrest 81 81
Pain 72 72
No Information 69 69
Bacterial Infection 57 81
Unspecified Infection 57 75
Rupture 50 50
Fistula 48 48
Embolism/Embolus 44 44
Arrhythmia 43 43
Unspecified Tissue Injury 34 34
Heart Block 33 33
Thromboembolism 32 32
Great Vessel Perforation 31 31
Stenosis 28 28
Foreign Body Embolism 27 27
Thrombosis 25 25
Cramp(s) /Muscle Spasm(s) 23 23
Bruise/Contusion 22 52
Myocardial Infarction 21 21
Bradycardia 21 21
Pulmonary Embolism 20 20
Tachycardia 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 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 Aug-12-2024
29 Merit Medical Systems, Inc. II Jun-27-2024
30 Merit Medical Systems, Inc. II May-20-2024
31 Merit Medical Systems, Inc. II May-10-2023
32 Merit Medical Systems, Inc. II Aug-12-2021
33 Merit Medical Systems, Inc. II Aug-10-2021
34 Merit Medical Systems, Inc. II May-11-2020
35 Oscor Inc. II Feb-17-2022
36 Oscor, Inc. II Apr-01-2021
37 St. Jude Medical II Jul-12-2024
38 Terumo Medical Corporation I May-28-2019
39 W. L. Gore & Associates Inc. II May-11-2020
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