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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, intravascular, therapeutic, long-term greater than 30 days
Product CodeLJS
Regulation Number 880.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCESS VASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
ACCESS VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 2
AMECO MEDICAL INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 4
ARROW INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX,
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD ACCESS SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 1
BIOWY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC (BARD HAS JOINED BD)
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 10
C.R.BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK CORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
FOOTPRINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FOOTPRINT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INTERRAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JET MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
L&Z US, INC.
  SUBSTANTIALLY EQUIVALENT 6
MARVAO MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 5
MEDCOMP (MEDICAL COMPONENTS)
  SUBSTANTIALLY EQUIVALENT 3
MEDCOMP (MEDICAL COMPONENTS, INC.)
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL COMPONENTS INC
  SUBSTANTIALLY EQUIVALENT 7
MEDICAL COMPONENTS, INC (DBA MEDCOMP_
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS, INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 1
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 15
NOSTIX LLC
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
PICCOLO MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
PIPER ACCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
R4 VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROMEDEX INTERNATIONAL SRL
  SUBSTANTIALLY EQUIVALENT 2
SEMPRUS BIOSCIENCES
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT MEDICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
VASONOVA INC.
  SUBSTANTIALLY EQUIVALENT 2
VYGON USA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 841 842
2015 1306 1306
2016 1122 1122
2017 2099 2099
2018 2323 2323
2019 2051 2051
2020 2539 2539
2021 3084 3084
2022 3256 3256
2023 2803 2803
2024 1384 1384

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 6102 6102
Break 2477 2477
Material Deformation 1646 1646
Leak/Splash 1301 1301
Fracture 1162 1162
Adverse Event Without Identified Device or Use Problem 982 982
Crack 919 919
Defective Component 849 849
Material Frayed 666 666
Component Incompatible 575 575
Material Separation 505 505
Detachment of Device or Device Component 494 494
Detachment Of Device Component 469 469
Failure to Infuse 430 430
Hole In Material 389 389
Material Puncture/Hole 354 354
Device Dislodged or Dislocated 327 327
Difficult to Remove 308 308
Material Rupture 298 298
Material Twisted/Bent 297 297
Deformation Due to Compressive Stress 243 243
Obstruction of Flow 238 238
Contamination /Decontamination Problem 233 233
Device Operates Differently Than Expected 233 233
Material Fragmentation 216 216
Physical Resistance/Sticking 208 208
Material Split, Cut or Torn 203 203
Insufficient Information 199 199
Split 188 188
Data Problem 183 183
Kinked 180 180
Migration or Expulsion of Device 180 180
Occlusion Within Device 166 166
Failure to Advance 142 142
Malposition of Device 140 140
Unraveled Material 140 140
Backflow 133 133
Material Integrity Problem 127 127
Burst Container or Vessel 126 126
Difficult or Delayed Separation 123 123
Physical Resistance 121 121
Stretched 118 118
Improper or Incorrect Procedure or Method 117 117
Difficult to Flush 117 117
Difficult to Insert 104 104
Appropriate Term/Code Not Available 100 100
Difficult to Advance 93 93
Positioning Problem 86 86
Device Contamination with Chemical or Other Material 83 83
Flushing Problem 82 82
Loss of or Failure to Bond 82 82
Entrapment of Device 80 80
Device Markings/Labelling Problem 78 78
Component Missing 74 74
Suction Problem 74 74
Migration 72 72
Disconnection 71 71
Defective Device 68 68
Nonstandard Device 65 65
Bent 63 63
Material Protrusion/Extrusion 63 63
Tear, Rip or Hole in Device Packaging 62 62
Sticking 62 62
Complete Blockage 61 61
Expiration Date Error 57 57
Torn Material 55 55
Patient-Device Incompatibility 54 54
Infusion or Flow Problem 52 52
Misassembled 50 50
Loose or Intermittent Connection 49 49
Aspiration Issue 49 49
Connection Problem 49 49
Knotted 48 48
Unable to Obtain Readings 44 44
Fitting Problem 44 44
No Apparent Adverse Event 42 42
Material Perforation 40 40
Device Damaged Prior to Use 40 40
Corroded 40 40
Partial Blockage 39 39
Separation Failure 36 36
Mushroomed 34 34
Air Leak 34 34
Peeled/Delaminated 33 33
Therapeutic or Diagnostic Output Failure 33 33
Component Falling 31 31
Incorrect, Inadequate or Imprecise Result or Readings 30 30
Retraction Problem 30 30
Improper Flow or Infusion 30 30
Expulsion 30 30
Noise, Audible 28 28
No Flow 27 27
Microbial Contamination of Device 27 27
Device Slipped 26 26
Contamination 26 26
Material Discolored 25 25
Coagulation in Device or Device Ingredient 24 24
Activation, Positioning or Separation Problem 24 24
Cut In Material 23 23
Restricted Flow rate 23 23

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8243 8243
No Known Impact Or Consequence To Patient 4930 4930
No Consequences Or Impact To Patient 4085 4085
Foreign Body In Patient 822 822
Insufficient Information 683 683
No Code Available 593 593
Swelling/ Edema 576 576
No Information 511 515
Erythema 500 500
Pain 393 393
No Patient Involvement 331 331
Device Embedded In Tissue or Plaque 264 264
Unspecified Infection 230 230
Extravasation 202 202
Swelling 187 187
Thrombus 152 152
Thrombosis 126 126
Thrombosis/Thrombus 113 113
Infiltration into Tissue 112 112
Bacterial Infection 107 107
Hemorrhage/Bleeding 103 103
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 82 82
Discomfort 74 74
Fever 63 63
Blood Loss 51 51
Death 47 47
Failure of Implant 45 45
Reaction 45 45
Dyspnea 42 42
Hypersensitivity/Allergic reaction 41 41
Sepsis 39 39
Injury 37 37
Embolism 35 35
Itching Sensation 34 34
Rash 32 32
Hematoma 32 32
Inflammation 31 31
Tissue Damage 31 31
Edema 30 30
Chemical Exposure 29 29
Burning Sensation 28 28
Purulent Discharge 27 27
Skin Inflammation/ Irritation 27 27
Needle Stick/Puncture 26 26
Phlebitis 24 24
Chest Pain 23 23
Pleural Effusion 22 22
Perforation of Vessels 21 21
Cardiac Arrest 20 20
Bruise/Contusion 19 19
Arrhythmia 19 19
Anxiety 19 19
Numbness 18 18
Fluid Discharge 18 18
Cellulitis 18 18
Nausea 16 16
Exposure to Body Fluids 15 15
Embolus 14 14
Laceration(s) 14 14
Thromboembolism 14 14
Cardiac Tamponade 14 14
Complaint, Ill-Defined 13 13
Venipuncture 13 13
Ventricular Tachycardia 12 12
Respiratory Distress 12 12
Vessel Or Plaque, Device Embedded In 12 12
Unspecified Tissue Injury 12 12
Air Embolism 11 11
Tachycardia 11 11
Tingling 11 11
Low Blood Pressure/ Hypotension 10 10
Patient Problem/Medical Problem 10 10
Fungal Infection 10 10
Urticaria 9 9
Stroke/CVA 9 9
Discharge 9 9
Local Reaction 9 9
Pneumonia 8 8
Septic Shock 8 8
Skin Discoloration 8 8
Embolism/Embolus 8 8
Pericardial Effusion 7 7
Premature Labor 7 7
Skin Irritation 7 7
Chills 7 7
Irritation 7 7
Occlusion 6 6
Pneumothorax 6 6
Perforation 6 6
Scar Tissue 6 6
Anaphylactoid 6 6
Great Vessel Perforation 6 6
Anaphylactic Shock 6 6
High Blood Pressure/ Hypertension 6 6
Hypoglycemia 5 5
Foreign Body Reaction 5 5
Pulmonary Embolism 5 5
Bradycardia 5 5
Necrosis 5 5
Alteration In Body Temperature 5 5

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Oct-05-2023
2 ARROW INTERNATIONAL Inc. II Sep-15-2023
3 Access Vascular, Inc II Oct-13-2023
4 Access Vascular, Inc II May-18-2023
5 Access Vascular, Inc. II Nov-08-2022
6 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-11-2018
7 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
8 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-14-2017
9 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-07-2016
10 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-05-2016
11 Angiodynamics Worldwide Headquarters II Feb-21-2012
12 Angiodynamics Worldwide Headquarters II Jan-26-2012
13 Angiodynamics Worldwide Headquarters III Jan-11-2012
14 Angiodynamics, Inc. II Jun-17-2020
15 Arrow International Inc II Feb-14-2020
16 Arrow International Inc II Jun-16-2019
17 Arrow International Inc II May-16-2019
18 Arrow International Inc II Sep-19-2018
19 Arrow International Inc II Jul-08-2018
20 Arrow International Inc II May-30-2018
21 Arrow International Inc II Apr-10-2018
22 Arrow International Inc II Mar-14-2018
23 Arrow International Inc II Feb-22-2018
24 Arrow International Inc II Feb-13-2018
25 Arrow International Inc II Nov-28-2017
26 Arrow International Inc II Jun-27-2017
27 Arrow International Inc II Jun-12-2017
28 Arrow International Inc II Mar-08-2017
29 Arrow International Inc II Feb-22-2017
30 Arrow International Inc II Sep-09-2016
31 Arrow International Inc II Nov-04-2015
32 Arrow International Inc II Oct-15-2015
33 Arrow International Inc II Aug-25-2015
34 Arrow International Inc II Apr-24-2014
35 Arrow International Inc II May-26-2010
36 Arrow International Inc II Jun-24-2009
37 Bard Access Systems II Sep-23-2015
38 Bard Access Systems III Jul-08-2015
39 Bard Access Systems II Mar-13-2015
40 Bard Access Systems II Jul-11-2011
41 Bard Access Systems II Jan-06-2011
42 Bard Access Systems Inc. II Jul-01-2021
43 Bard Access Systems Inc. II Jun-30-2021
44 Bard Access Systems Inc. II May-20-2021
45 Bard Access Systems Inc. II Feb-06-2018
46 Bard Peripheral Vascular Inc II Feb-01-2023
47 Becton Dickinson & Company II May-21-2020
48 Cook, Inc. I Feb-23-2011
49 Medical Components, Inc dba MedComp II Oct-25-2019
50 Medical Components, Inc dba MedComp II Feb-28-2013
51 Navilyst Medical, Inc II Oct-07-2014
52 Navilyst Medical, Inc., an AngioDyamics Company II Jun-14-2016
53 Pfm Medical Inc II Dec-12-2014
54 Vygon Corporation II Mar-11-2013
55 Vygon Corporation II Jun-29-2011
56 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
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