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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 15
  SUBSTANTIALLY EQUIVALENT - KIT 1
NOSTIX LLC
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
PICCOLO MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
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 2520 2520

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 6678 6678
Break 2547 2547
Material Deformation 1746 1746
Leak/Splash 1311 1311
Fracture 1200 1200
Adverse Event Without Identified Device or Use Problem 1005 1005
Crack 939 939
Defective Component 891 891
Material Frayed 683 683
Component Incompatible 595 595
Material Separation 564 564
Detachment of Device or Device Component 503 503
Detachment Of Device Component 469 469
Failure to Infuse 449 449
Hole In Material 389 389
Material Puncture/Hole 360 360
Device Dislodged or Dislocated 336 336
Difficult to Remove 323 323
Material Twisted/Bent 322 322
Material Rupture 302 302
Contamination /Decontamination Problem 263 263
Deformation Due to Compressive Stress 246 246
Obstruction of Flow 241 241
Device Operates Differently Than Expected 233 233
Material Fragmentation 217 217
Physical Resistance/Sticking 212 212
Material Split, Cut or Torn 207 207
Data Problem 202 202
Insufficient Information 199 199
Split 188 188
Migration or Expulsion of Device 182 182
Kinked 180 180
Occlusion Within Device 166 166
Unraveled Material 144 144
Failure to Advance 142 142
Malposition of Device 140 140
Backflow 137 137
Difficult or Delayed Separation 135 135
Material Integrity Problem 131 131
Stretched 126 126
Burst Container or Vessel 126 126
Improper or Incorrect Procedure or Method 125 125
Difficult to Flush 124 124
Physical Resistance 121 121
Loss of or Failure to Bond 110 110
Difficult to Insert 105 105
Appropriate Term/Code Not Available 100 100
Difficult to Advance 99 99
Device Markings/Labelling Problem 88 88
Positioning Problem 87 87

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9153 9153
No Known Impact Or Consequence To Patient 4930 4930
No Consequences Or Impact To Patient 4085 4085
Foreign Body In Patient 861 861
Insufficient Information 734 734
Swelling/ Edema 609 609
No Code Available 593 593
No Information 511 515
Erythema 510 510
Pain 437 437
No Patient Involvement 331 331
Device Embedded In Tissue or Plaque 266 266
Extravasation 238 238
Unspecified Infection 236 236
Swelling 187 187
Thrombus 152 152
Thrombosis/Thrombus 128 128
Thrombosis 126 126
Infiltration into Tissue 117 117
Hemorrhage/Bleeding 116 116
Bacterial Infection 107 107
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 85 85
Discomfort 81 81
Fever 64 64
Blood Loss 51 51
Failure of Implant 48 48
Death 47 47
Reaction 45 45
Hypersensitivity/Allergic reaction 43 43
Dyspnea 43 43
Sepsis 41 41
Injury 37 37
Embolism 35 35
Itching Sensation 34 34
Inflammation 34 34
Hematoma 33 33
Rash 32 32
Tissue Damage 31 31
Chemical Exposure 30 30
Edema 30 30
Burning Sensation 30 30
Skin Inflammation/ Irritation 29 29
Purulent Discharge 28 28
Needle Stick/Puncture 27 27
Phlebitis 25 25
Chest Pain 23 23
Pleural Effusion 22 22
Perforation of Vessels 21 21
Anxiety 21 21
Arrhythmia 20 20

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 Argon Medical Devices, Inc II Aug-16-2024
16 Arrow International Inc II Feb-14-2020
17 Arrow International Inc II Jun-16-2019
18 Arrow International Inc II May-16-2019
19 Arrow International Inc II Sep-19-2018
20 Arrow International Inc II Jul-08-2018
21 Arrow International Inc II May-30-2018
22 Arrow International Inc II Apr-10-2018
23 Arrow International Inc II Mar-14-2018
24 Arrow International Inc II Feb-22-2018
25 Arrow International Inc II Feb-13-2018
26 Arrow International Inc II Nov-28-2017
27 Arrow International Inc II Jun-27-2017
28 Arrow International Inc II Jun-12-2017
29 Arrow International Inc II Mar-08-2017
30 Arrow International Inc II Feb-22-2017
31 Arrow International Inc II Sep-09-2016
32 Arrow International Inc II Nov-04-2015
33 Arrow International Inc II Oct-15-2015
34 Arrow International Inc II Aug-25-2015
35 Arrow International Inc II Apr-24-2014
36 Arrow International Inc II May-26-2010
37 Arrow International Inc II Jun-24-2009
38 Bard Access Systems II Sep-23-2015
39 Bard Access Systems III Jul-08-2015
40 Bard Access Systems II Mar-13-2015
41 Bard Access Systems II Jul-11-2011
42 Bard Access Systems II Jan-06-2011
43 Bard Access Systems Inc. II Jul-01-2021
44 Bard Access Systems Inc. II Jun-30-2021
45 Bard Access Systems Inc. II May-20-2021
46 Bard Access Systems Inc. II Feb-06-2018
47 Bard Peripheral Vascular Inc II Feb-01-2023
48 Becton Dickinson & Company II May-21-2020
49 Cook, Inc. I Feb-23-2011
50 Medical Components, Inc dba MedComp II Oct-25-2019
51 Medical Components, Inc dba MedComp II Feb-28-2013
52 Navilyst Medical, Inc II Oct-07-2014
53 Navilyst Medical, Inc., an AngioDyamics Company II Jun-14-2016
54 Pfm Medical Inc II Dec-12-2014
55 Vygon Corporation II Mar-11-2013
56 Vygon Corporation II Jun-29-2011
57 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018
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