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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 5
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 3
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
  1.  K172117  Prelude Pursuit Splittable Sheath Introducer
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 3
  1.  K172117  Prelude Pursuit Splittable Sheath Introducer
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 3043
2022 2165 4671

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2244 2269
Adverse Event Without Identified Device or Use Problem 1674 2902
Fluid Leak 1493 1493
Detachment of Device or Device Component 1145 1145
Break 874 1057
Material Deformation 642 642
Leak/Splash 628 690
Gas Leak 512 512
Difficult to Insert 331 331
Component Misassembled 329 329
Unraveled Material 278 278
Material Split, Cut or Torn 274 274
Difficult to Advance 234 234
Fracture 231 231
Difficult to Remove 229 229
Failure to Advance 220 220
Physical Resistance/Sticking 195 195
Material Frayed 193 193
Obstruction of Flow 191 191
Backflow 187 187
Detachment Of Device Component 175 175
Device-Device Incompatibility 172 172
Patient-Device Incompatibility 170 170
Flaked 170 170
Material Puncture/Hole 165 165
Device Contamination with Chemical or Other Material 144 144
Material Integrity Problem 137 137
Patient Device Interaction Problem 122 122
Appropriate Term/Code Not Available 118 118
Use of Device Problem 112 112
Insufficient Information 107 1395
Peeled/Delaminated 106 106
Material Twisted/Bent 105 105
Contamination /Decontamination Problem 104 104
Crack 87 87
Entrapment of Device 85 85
Material Fragmentation 82 82
Air Leak 81 81
Stretched 80 80
Kinked 74 74
Deformation Due to Compressive Stress 71 71
Improper or Incorrect Procedure or Method 67 67
Separation Problem 65 65
Device Operates Differently Than Expected 63 63
Defective Component 61 61
Split 55 55
Device Damaged Prior to Use 52 52
Connection Problem 49 49
Activation, Positioning or SeparationProblem 49 49
Torn Material 46 46
Material Too Rigid or Stiff 38 38
Device Contaminated During Manufacture or Shipping 37 37
Defective Device 37 37
Material Perforation 32 32
Positioning Problem 29 29
Physical Resistance 29 29
Device Damaged by Another Device 28 28
Material Protrusion/Extrusion 28 28
Packaging Problem 26 39
Device Dislodged or Dislocated 26 26
Component Missing 25 25
Mechanical Problem 25 25
Scratched Material 25 25
Bent 24 24
Unsealed Device Packaging 23 23
Air/Gas in Device 23 23
Inadequacy of Device Shape and/or Size 22 22
Material Rupture 22 22
Difficult or Delayed Separation 22 22
Loose or Intermittent Connection 21 21
Device Contamination with Body Fluid 21 21
No Apparent Adverse Event 19 19
Device Markings/Labelling Problem 18 18
Off-Label Use 18 18
Fitting Problem 16 16
Sticking 15 15
Partial Blockage 15 15
Migration 15 15
Tear, Rip or Hole in Device Packaging 14 14
Protective Measures Problem 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Difficult or Delayed Positioning 14 14
Nonstandard Device 14 14
Migration or Expulsion of Device 13 13
Hole In Material 12 12
Corroded 12 12
Delivered as Unsterile Product 12 12
Sharp Edges 12 12
Incorrect, Inadequate or Imprecise Resultor Readings 11 11
Material Too Soft/Flexible 11 11
Accessory Incompatible 11 11
Contamination 10 10
Retraction Problem 10 10
Malposition of Device 10 10
Disconnection 9 9
Therapeutic or Diagnostic Output Failure 9 9
Knotted 9 9
Device Packaging Compromised 9 9
Device Handling Problem 9 9
Mechanical Jam 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4058 4058
No Consequences Or Impact To Patient 3648 3797
No Known Impact Or Consequence To Patient 1346 1346
Blood Loss 522 527
Cardiac Perforation 489 489
Vascular Dissection 483 774
No Patient Involvement 472 478
No Code Available 404 404
Foreign Body In Patient 318 318
Device Embedded In Tissue or Plaque 262 262
Hemorrhage/Bleeding 239 458
Hematoma 188 473
Perforation of Vessels 174 174
Death 167 167
Insufficient Information 165 165
No Information 124 124
Pericardial Effusion 108 108
Cardiac Tamponade 99 99
Air Embolism 83 83
Stroke/CVA 82 82
Low Blood Pressure/ Hypotension 78 78
Aneurysm 72 72
Pseudoaneurysm 70 70
Perforation 63 63
Rupture 55 55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 1413
Pain 52 52
Cardiac Arrest 47 47
Fistula 36 36
Thrombosis 34 34
Intimal Dissection 34 34
Unspecified Infection 32 32
Injury 31 31
Thrombus 30 30
Thrombosis/Thrombus 29 29
Unspecified Vascular Problem 28 288
Myocardial Infarction 25 25
Obstruction/Occlusion 25 25
Arrhythmia 23 23
Tissue Damage 22 22
Embolism 22 22
Cardiogenic Shock 21 21
Needle Stick/Puncture 21 21
Anaphylactic Shock 21 21
Aortic Dissection 21 21
Embolism/Embolus 19 19
Great Vessel Perforation 19 19
Bacterial Infection 18 18
Foreign Body Embolism 18 18
Ischemia 18 18
Bruise/Contusion 17 47
Retroperitoneal Hemorrhage 17 129
Transient Ischemic Attack 17 17
Atrial Perforation 16 16
Occlusion 16 16
Unspecified Tissue Injury 16 16
Laceration(s) 16 16
Pneumothorax 15 15
Calcium Deposits/Calcification 15 15
Vessel Or Plaque, Device Embedded In 14 14
Cramp(s) /Muscle Spasm(s) 14 14
Tachycardia 14 14
Reaction 14 14
Ventricular Fibrillation 12 12
Phlebitis 12 12
Thromboembolism 11 11
Patient Problem/Medical Problem 11 11
Stenosis 11 11
Embolus 11 11
Hemostasis 10 10
Heart Block 10 10
Bradycardia 10 10
Swelling 10 10
ST Segment Elevation 9 9
Edema 9 9
Atrial Fibrillation 8 8
Pleural Effusion 8 8
Non specific EKG/ECG Changes 8 8
Extravasation 7 7
Vasoconstriction 7 7
Paralysis 7 7
Vascular System (Circulation), Impaired 7 7
Inflammation 7 7
Exsanguination 7 7
Pulmonary Embolism 6 6
Complete Heart Block 6 6
Ischemic Heart Disease 6 6
Swelling/ Edema 6 6
Exposure to Body Fluids 6 18
Nerve Damage 6 6
Dizziness 6 6
Sepsis 6 6
Heart Failure/Congestive Heart Failure 6 6
Erythema 5 5
Discomfort 5 5
Hemothorax 5 5
Chest Pain 5 5
Vomiting 5 5
Nausea 5 5
Loss of consciousness 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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