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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 1
ABIOMED INC.
  SUBSTANTIALLY EQUIVALENT 2
ABIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 2
ACUTUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 2
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BARD PERIPHERAL VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 4
BIOCARDIA, INC.
  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
C.R.BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
CONTRACT MEDICAL INTERNATIONAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 10
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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
ENDOPHYS HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 2
EPIEP, INC
  SUBSTANTIALLY EQUIVALENT 1
FREUDENBERG MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
FREUDENBERG MEDICAL MIS, INC
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT - KIT 1
GREATBATCH MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KALILA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
KEYSTONE HEART, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDTRONIC CRYOCATH LP
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 3
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
RAM MEDICAL INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RHYTHM XIENCE, INC. (RXI)
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TALON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL COPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
TRANSAORTIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRANSSEPTAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1668 1668
2018 1901 1901
2019 2449 2449
2020 2465 2465
2021 2833 2843
2022 1467 3027

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2045 2045
Adverse Event Without Identified Device or Use Problem 1586 2335
Fluid Leak 1399 1399
Detachment of Device or Device Component 1110 1110
Break 840 840
Leak/Splash 615 615
Material Deformation 602 602
Gas Leak 496 496
Component Misassembled 329 329
Difficult to Insert 305 305
Unraveled Material 267 267
Material Split, Cut or Torn 245 245
Difficult to Remove 222 222
Fracture 221 221
Difficult to Advance 217 217
Failure to Advance 207 207
Material Frayed 189 189
Physical Resistance/Sticking 180 180
Detachment Of Device Component 175 175
Backflow 174 174
Flaked 165 165
Patient-Device Incompatibility 164 164
Obstruction of Flow 163 163
Material Puncture/Hole 142 142
Device Contamination with Chemical or Other Material 142 142
Device-Device Incompatibility 129 129
Material Integrity Problem 127 127
Appropriate Term/Code Not Available 117 117
Patient Device Interaction Problem 113 113
Use of Device Problem 108 108
Contamination /Decontamination Problem 95 95
Insufficient Information 95 916
Material Twisted/Bent 89 89
Peeled/Delaminated 89 89
Crack 87 87
Entrapment of Device 83 83
Air Leak 81 81
Material Fragmentation 81 81
Stretched 78 78
Kinked 74 74
Deformation Due to Compressive Stress 68 68
Improper or Incorrect Procedure or Method 65 65
Separation Problem 64 64
Device Operates Differently Than Expected 63 63
Defective Component 61 61
Split 55 55
Device Damaged Prior to Use 52 52
Connection Problem 48 48
Activation, Positioning or SeparationProblem 48 48
Torn Material 46 46
Defective Device 36 36
Material Too Rigid or Stiff 35 35
Device Contaminated During Manufacture or Shipping 34 34
Material Perforation 32 32
Physical Resistance 29 29
Material Protrusion/Extrusion 28 28
Positioning Problem 27 27
Device Damaged by Another Device 27 27
Device Dislodged or Dislocated 25 25
Component Missing 25 25
Scratched Material 25 25
Packaging Problem 25 25
Mechanical Problem 24 24
Bent 24 24
Unsealed Device Packaging 23 23
Material Rupture 22 22
Inadequacy of Device Shape and/or Size 21 21
Device Contamination with Body Fluid 20 20
Air/Gas in Device 20 20
No Apparent Adverse Event 19 19
Loose or Intermittent Connection 19 19
Off-Label Use 18 18
Device Markings/Labelling Problem 18 18
Difficult or Delayed Separation 18 18
Fitting Problem 16 16
Sticking 15 15
Nonstandard Device 14 14
Difficult or Delayed Positioning 14 14
Migration 14 14
Protective Measures Problem 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Partial Blockage 13 13
Migration or Expulsion of Device 13 13
Tear, Rip or Hole in Device Packaging 13 13
Delivered as Unsterile Product 12 12
Hole In Material 12 12
Corroded 12 12
Sharp Edges 12 12
Incorrect, Inadequate or Imprecise Resultor Readings 11 11
Retraction Problem 10 10
Accessory Incompatible 10 10
Contamination 10 10
Disconnection 9 9
Knotted 9 9
Device Packaging Compromised 9 9
Malposition of Device 9 9
Device Handling Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Wrinkled 8 8
Device Issue 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3648 3648
No Clinical Signs, Symptoms or Conditions 3529 3529
No Known Impact Or Consequence To Patient 1346 1346
Blood Loss 522 522
Cardiac Perforation 484 484
No Patient Involvement 472 472
Vascular Dissection 442 733
No Code Available 404 404
Foreign Body In Patient 301 301
Device Embedded In Tissue or Plaque 261 261
Hemorrhage/Bleeding 224 334
Hematoma 180 361
Death 167 167
Perforation of Vessels 163 163
Insufficient Information 149 149
No Information 124 124
Pericardial Effusion 102 102
Cardiac Tamponade 91 91
Stroke/CVA 81 81
Air Embolism 81 81
Low Blood Pressure/ Hypotension 75 75
Aneurysm 70 70
Pseudoaneurysm 63 63
Perforation 61 61
Pain 50 50
Rupture 47 47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 47 950
Cardiac Arrest 45 45
Fistula 36 36
Intimal Dissection 34 34
Thrombosis 34 34
Unspecified Infection 32 32
Injury 31 31
Thrombus 30 30
Myocardial Infarction 25 25
Thrombosis/Thrombus 25 25
Embolism 22 22
Arrhythmia 22 22
Tissue Damage 22 22
Needle Stick/Puncture 21 21
Aortic Dissection 21 21
Anaphylactic Shock 21 21
Cardiogenic Shock 20 20
Obstruction/Occlusion 18 18
Ischemia 18 18
Unspecified Vascular Problem 18 28
Embolism/Embolus 17 17
Bruise/Contusion 17 17
Great Vessel Perforation 17 17
Transient Ischemic Attack 16 16
Bacterial Infection 16 16
Occlusion 16 16
Laceration(s) 16 16
Foreign Body Embolism 16 16
Unspecified Tissue Injury 16 16
Atrial Perforation 16 16
Pneumothorax 15 15
Tachycardia 14 14
Reaction 14 14
Vessel Or Plaque, Device Embedded In 14 14
Calcium Deposits/Calcification 13 13
Retroperitoneal Hemorrhage 13 88
Cramp(s) /Muscle Spasm(s) 12 12
Ventricular Fibrillation 12 12
Phlebitis 12 12
Embolus 11 11
Patient Problem/Medical Problem 11 11
Hemostasis 10 10
Swelling 10 10
Stenosis 10 10
ST Segment Elevation 9 9
Edema 9 9
Bradycardia 9 9
Heart Block 9 9
Non specific EKG/ECG Changes 8 8
Atrial Fibrillation 8 8
Pleural Effusion 8 8
Vasoconstriction 7 7
Exsanguination 7 7
Extravasation 7 7
Inflammation 7 7
Vascular System (Circulation), Impaired 7 7
Thromboembolism 7 7
Complete Heart Block 6 6
Swelling/ Edema 6 6
Pulmonary Embolism 6 6
Exposure to Body Fluids 6 6
Nerve Damage 6 6
Sepsis 6 6
Paralysis 6 6
Dizziness 6 6
Vomiting 5 5
Discomfort 5 5
Loss of consciousness 5 5
Cardiomyopathy 5 5
Chest Pain 5 5
Nausea 5 5
Erythema 5 5
Hemothorax 5 5
Heart Failure/Congestive Heart Failure 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 Acutus Medical Inc II Apr-23-2020
5 Angiodynamics Inc. (Navilyst Medical Inc.) II Apr-21-2021
6 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
7 Argon Medical Devices, Inc II Sep-21-2021
8 Argon Medical Devices, Inc II Feb-05-2021
9 Arrow International Inc II Feb-14-2020
10 Arrow International Inc II Sep-23-2019
11 Arrow International Inc II Jul-30-2018
12 Arrow International Inc II May-30-2018
13 Arrow International Inc II Apr-10-2018
14 Arrow International Inc II Apr-02-2018
15 Arrow International Inc II Mar-05-2018
16 Arrow International Inc II Jun-27-2017
17 Arrow International Inc II Jun-12-2017
18 BARD PERIPHERAL VASCULAR, INC I Jan-18-2017
19 Baylis Medical Company Inc. II May-21-2020
20 Biosense Webster, Inc. II Mar-22-2021
21 Cook Inc. II Dec-16-2021
22 Cook Inc. II Oct-29-2021
23 Cook Inc. I Dec-23-2020
24 Cook Inc. II Feb-20-2019
25 Cook Inc. II Mar-02-2017
26 Creganna Medical Devices II Jun-14-2017
27 Freudenberg Medical, Llc II Apr-28-2022
28 Galt Medical Corporation II Jul-27-2018
29 Greatbatch Medical II Jul-29-2017
30 Greatbatch Medical II Jul-29-2017
31 Kalila Medical II Feb-09-2018
32 Medtronic Vascular Galway DBA Medtronic Ireland I May-27-2020
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 Merit Medical Systems, Inc. II Feb-22-2018
37 Merit Medical Systems, Inc. I Mar-24-2017
38 Merit Medical Systems, Inc. II Jan-05-2017
39 Oscor Inc. II Feb-17-2022
40 Oscor, Inc. II Apr-01-2021
41 Sterilmed Inc I Dec-29-2017
42 Terumo Medical Corp II Dec-08-2017
43 Terumo Medical Corporation I May-28-2019
44 Terumo Medical Corporation II Feb-26-2018
45 Terumo Medical Corporation II May-04-2017
46 W. L. Gore & Associates Inc. II May-11-2020
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