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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wire, guide, catheter
Product CodeDQX
Regulation Number 870.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 12
ABBOTT VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 6
ABBOTT VASCULAR-CARDIAC THERAPIES
  SUBSTANTIALLY EQUIVALENT 3
ACME-MONACO CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 28
ASAHI INTECC CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASHITAKA FACTORY OF TERUMO COPORATION
  SUBSTANTIALLY EQUIVALENT 1
ASHITAKA FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERICS NLE
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
BOSTON SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 1
BRIDGEPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
BRIVANT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BRIVANT LIMITED (LAKE REGION MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
BRIVANT, LTD.
  SUBSTANTIALLY EQUIVALENT 6
CARDIO FLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOSOLUTIONS INC
  SUBSTANTIALLY EQUIVALENT 1
CENTURION MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
COEUR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 12
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
DISTAL ACCESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
EMBRACE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
FILMEC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
FILMECC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
FILMECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
FILMECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLAT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FMD CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUIDEPATH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
LAKE REGION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MFG., INC.
  SUBSTANTIALLY EQUIVALENT 1
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 1
MEDIVALVE LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC CORE VALVE, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC COREVALVE, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 14
MICRO THERAPEUTICS, INC D/B/A: EV3 INC
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRUS ENDOVASCULAR CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NANO4IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 2
NAVIS MEDICAL,INC
  SUBSTANTIALLY EQUIVALENT 1
NEEDLETECH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEO METRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOMETRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OPSENS
  SUBSTANTIALLY EQUIVALENT 1
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 3
OPSENS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
PHENOX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA CARDIO ACCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 3
SEVEN SONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHEPHERD SCIENTIFIC INC
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
  SUBSTANTIALLY EQUIVALENT 1
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUREFIRE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU INNOMED MEDICAL DEVICE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
TATARA VASCULAR, LLC.
  SUBSTANTIALLY EQUIVALENT 1
TECHDEVICE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TEXAS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VADISWIRE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 7
VESATEK, LLC
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1316 1316
2015 1322 1322
2016 1463 1463
2017 1523 1523
2018 1736 1736
2019 1677 1677
2020 1536 2024
2021 1712 3054
2022 1647 1647
2023 2069 2069
2024 1468 1468

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 2344 2344
Material Separation 1996 2972
Break 1980 1980
Detachment Of Device Component 1565 1565
Fracture 1538 1538
Peeled/Delaminated 1450 1450
Detachment of Device or Device Component 1344 1344
Adverse Event Without Identified Device or Use Problem 1294 1416
Entrapment of Device 1084 2060
Difficult to Advance 1013 1013
Failure to Advance 759 759
Stretched 670 670
Material Deformation 553 553
Unraveled Material 539 539
Improper or Incorrect Procedure or Method 469 469
Material Integrity Problem 464 464
Deformation Due to Compressive Stress 426 426
Difficult To Position 350 350
Physical Resistance/Sticking 345 345
Insufficient Information 301 301
Material Split, Cut or Torn 298 298
Material Twisted/Bent 263 263
Kinked 233 233
Device Damaged by Another Device 202 202
Material Fragmentation 191 191
Flaked 164 164
Physical Resistance 157 157
Positioning Problem 151 151
Material Frayed 150 150
Device Operates Differently Than Expected 149 149
Product Quality Problem 136 136
Material Protrusion/Extrusion 110 110
Off-Label Use 94 94
Device Damaged Prior to Use 86 86
Use of Device Problem 85 85
Bent 80 80
Difficult to Insert 79 79
Fluid/Blood Leak 73 73
Contamination /Decontamination Problem 64 64
Device Contamination with Chemical or Other Material 62 62
Material Too Soft/Flexible 61 61
Leak/Splash 60 60
Device Dislodged or Dislocated 57 57
Defective Device 53 53
Device Contaminated During Manufacture or Shipping 51 51
Unsealed Device Packaging 49 49
Activation, Positioning or Separation Problem 49 49
Component Misassembled 47 47
Occlusion Within Device 46 46
Delamination 46 46

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4993 4993
No Clinical Signs, Symptoms or Conditions 4301 5399
Foreign Body In Patient 1791 1791
Device Embedded In Tissue or Plaque 1516 1516
No Known Impact Or Consequence To Patient 1302 1790
Vascular Dissection 557 679
No Patient Involvement 545 545
Insufficient Information 408 408
Perforation of Vessels 397 519
Perforation 320 320
Vessel Or Plaque, Device Embedded In 296 296
Death 279 279
Pericardial Effusion 223 223
Cardiac Tamponade 213 213
Cardiac Perforation 202 202
No Code Available 198 198
Low Blood Pressure/ Hypotension 197 197
No Information 175 175
Intimal Dissection 131 131
Hemorrhage/Bleeding 131 131
Myocardial Infarction 111 111
Hematoma 77 77
Stroke/CVA 74 74
Obstruction/Occlusion 72 72
Cardiac Arrest 70 70
Pain 66 66
Patient Problem/Medical Problem 55 55
Blood Loss 54 54
Occlusion 54 54
Thrombosis 51 51
Vasoconstriction 50 50
Embolism 50 50
Hemoptysis 49 49
Rupture 42 42
Intracranial Hemorrhage 37 37
Embolism/Embolus 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Thrombosis/Thrombus 32 32
Chest Pain 30 30
Injury 28 28
Laceration(s) 27 27
Bradycardia 27 27
Hemorrhage, Subarachnoid 26 26
Headache 26 26
Arrhythmia 25 25
Angina 24 24
Thrombus 24 24
Tissue Damage 22 22
Cardiogenic Shock 20 20
Calcium Deposits/Calcification 20 20

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Mar-21-2024
2 Abbott Vascular II Jul-12-2011
3 Abbott Vascular, Inc. II Dec-20-2013
4 Anewmed Corporation II Oct-31-2019
5 Argon Medical Devices, Inc I May-07-2020
6 Argon Medical Devices, Inc II May-26-2009
7 Arrow International Inc II Jan-23-2020
8 Arrow International Inc II May-30-2018
9 Arrow International Inc II Apr-10-2018
10 Arrow International Inc II Apr-02-2018
11 Arrow International Inc II Jun-12-2017
12 Arrow International Inc II Sep-07-2016
13 Arrow International Inc II Jul-12-2016
14 Arrow International Inc II Feb-17-2011
15 Arrow International Inc II Sep-25-2010
16 Bard Peripheral Vascular Inc II Sep-06-2024
17 Baylis Medical Corp * II Dec-01-2015
18 Baylis Medical Corp * II Apr-13-2015
19 Boston Scientific Corporation II Feb-20-2019
20 Boston Scientific Corporation II Apr-12-2016
21 Boston Scientific Corporation II Aug-23-2011
22 Boston Scientific Corporation II Jan-07-2011
23 Boston Scientific Corporation II Jul-22-2010
24 Boston Scientific Corporation II Jun-04-2010
25 Boston Scientific Corporation II Jun-24-2009
26 Cook Inc. I Nov-03-2020
27 Cook Inc. II Mar-09-2018
28 Cook Inc. I Aug-25-2016
29 Cook Incorporated II Sep-28-2022
30 Cook Incorporated II Sep-09-2022
31 Cordis Corporation II Jan-13-2010
32 EXP Pharmaceutical Services Corp II Jul-24-2015
33 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
34 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
35 Medtronic Vascular I Nov-15-2013
36 Merit Medical Systems, Inc. II Jun-26-2015
37 Merit Medical Systems, Inc. II Apr-22-2014
38 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
39 Nipro Medical Corporation II Oct-25-2012
40 Nitinol Devices and Components, Inc. I Jun-25-2014
41 SentreHeart Inc I Nov-09-2016
42 St. Jude Medical II Sep-18-2009
43 St. Jude Medical II Aug-17-2009
44 Stryker Neurovascular II May-31-2024
45 Stryker Neurovascular II May-28-2024
46 Stryker Neurovascular II Oct-29-2019
47 Terumo Medical Corporation II Jul-20-2011
48 Volcano Corporation II Jun-25-2015
49 Volcano Corporation II Feb-01-2012
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