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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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New Search show TPLC since Back to Search Results
Device catheter, percutaneous
Product CodeDQY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT (ST. JUDE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
ACROSTAK (SCHWEIZ) AG
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELELFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BALT USA LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CATHERA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
CERUS ENDOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CREGANNA MEDICAL ALSO DOING BUSINESS AS CEGANNA TACTX MEDICA
  SUBSTANTIALLY EQUIVALENT 1
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CURATIA MEDICAL CO.
  SUBSTANTIALLY EQUIVALENT 1
HAOLANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMDS OPERATIONS B.V.
  SUBSTANTIALLY EQUIVALENT 4
IMPERATIVE CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO INC.
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO, INC
  SUBSTANTIALLY EQUIVALENT 3
MARVAO MEDICAL DEVICES LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS, INC., D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO VENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO VENTION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROTHERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC., A TERUMO GROUP COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MIVI NEUROSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
MIVI NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
NITILOOP LTD.
  SUBSTANTIALLY EQUIVALENT 2
ORBUSNEICH MEDICAL TRADING INC.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL
  SUBSTANTIALLY EQUIVALENT 2
Q'APEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
QXMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
REFLOW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
RIST NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROUTE 92 MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
ROUTE 92 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROXWOOD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
SEIGLA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEQUENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TEXAS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRACTUS VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 2
TRANSIT SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
TRANSIT SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 2
TRAVERSE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
UPSTREAM PERIPHERAL TECHNOLOGIES, LTD
  SUBSTANTIALLY EQUIVALENT 1
UPSTREAM PERIPHERAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 4
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 5
VASCULAR SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE AND ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 1
XABLECATH, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 2486 2486
2018 2854 2854
2019 2902 2902
2020 2891 2891
2021 3009 3009
2022 1545 1545

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3198 3198
Adverse Event Without Identified Device or Use Problem 1728 1728
Break 1607 1607
Material Deformation 1384 1384
Detachment of Device or Device Component 945 945
Leak/Splash 742 742
Physical Resistance/Sticking 705 705
Failure to Advance 593 593
Device Damaged Prior to Use 477 477
Material Separation 467 467
Kinked 442 442
Deflation Problem 421 421
Difficult to Remove 397 397
Fluid Leak 378 378
Material Integrity Problem 353 353
Unraveled Material 345 345
Deformation Due to Compressive Stress 328 328
Peeled/Delaminated 327 327
Retraction Problem 296 296
Fracture 293 293
Crack 286 286
Difficult to Advance 261 261
Detachment Of Device Component 248 248
Inflation Problem 229 229
Burst Container or Vessel 228 228
Material Frayed 220 220
Entrapment of Device 190 190
Physical Resistance 181 181
Material Split, Cut or Torn 170 170
Difficult to Insert 162 162
Mechanical Problem 135 135
Material Twisted/Bent 135 135
Out-Of-Box Failure 123 123
Device Damaged by Another Device 122 122
Material Puncture/Hole 117 117
Device Operates Differently Than Expected 113 113
Insufficient Information 86 86
Bent 85 85
Material Fragmentation 82 82
Use of Device Problem 80 80
Device Contamination with Chemical or Other Material 76 76
Connection Problem 76 76
Complete Blockage 73 73
Hole In Material 71 71
Obstruction of Flow 67 67
Stretched 62 62
Device-Device Incompatibility 62 62
Device Dislodged or Dislocated 56 56
Accessory Incompatible 51 51
Gas Leak 48 48
Separation Problem 48 48
Device Markings/Labelling Problem 46 46
Appropriate Term/Code Not Available 43 43
Migration or Expulsion of Device 41 41
Unsealed Device Packaging 38 38
Packaging Problem 37 37
Torn Material 36 36
Improper or Incorrect Procedure or Method 35 35
Biocompatibility 34 34
Defective Device 34 34
Device Handling Problem 34 34
Partial Blockage 32 32
Contamination 26 26
Air Leak 25 25
Split 25 25
No Apparent Adverse Event 25 25
Manufacturing, Packaging or Shipping Problem 25 25
Migration 24 24
Component Missing 24 24
Unable to Obtain Readings 23 23
Loose or Intermittent Connection 23 23
Mechanical Jam 23 23
Positioning Problem 22 22
Device Sensing Problem 22 22
Material Perforation 21 21
Tear, Rip or Hole in Device Packaging 21 21
Defective Component 21 21
Activation, Positioning or SeparationProblem 20 20
Collapse 19 19
Fitting Problem 18 18
Patient Device Interaction Problem 18 18
Sticking 17 17
Patient-Device Incompatibility 16 16
Unintended Movement 16 16
No Flow 14 14
Compatibility Problem 14 14
Incorrect, Inadequate or Imprecise Resultor Readings 14 14
Delivered as Unsterile Product 13 13
Device Contaminated During Manufacture or Shipping 13 13
Folded 12 12
Material Too Rigid or Stiff 11 11
Difficult to Flush 11 11
Infusion or Flow Problem 11 11
Material Too Soft/Flexible 10 10
Device Fell 9 9
Disconnection 9 9
Occlusion Within Device 9 9
Product Quality Problem 8 8
Difficult or Delayed Positioning 8 8
Cut In Material 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6847 6847
No Clinical Signs, Symptoms or Conditions 3540 3540
No Known Impact Or Consequence To Patient 1649 1649
No Patient Involvement 770 770
Vascular Dissection 393 393
Device Embedded In Tissue or Plaque 332 332
Foreign Body In Patient 274 274
Insufficient Information 251 251
Pericardial Effusion 209 209
No Information 205 205
No Code Available 168 168
Perforation of Vessels 162 162
Death 142 142
Hematoma 129 129
Cardiac Perforation 122 122
Hemorrhage/Bleeding 112 112
Low Blood Pressure/ Hypotension 110 110
Perforation 101 101
Thrombosis/Thrombus 97 97
Vasoconstriction 91 91
Cardiac Tamponade 90 90
Stroke/CVA 88 88
Intracranial Hemorrhage 78 78
Rupture 72 72
Vessel Or Plaque, Device Embedded In 65 65
Injury 64 64
Air Embolism 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 57
Patient Problem/Medical Problem 57 57
Obstruction/Occlusion 55 55
Embolism 53 53
Stenosis 47 47
Occlusion 47 47
Thrombosis 46 46
Thromboembolism 46 46
Intimal Dissection 45 45
Pseudoaneurysm 43 43
Embolism/Embolus 41 41
Blood Loss 39 39
Aneurysm 37 37
Headache 35 35
Cardiac Arrest 34 34
Myocardial Infarction 33 33
Swelling/ Edema 32 32
Thrombus 31 31
Pain 31 31
Unspecified Infection 29 29
Unspecified Nervous System Problem 26 26
Restenosis 23 23
Unspecified Tissue Injury 22 22
Transient Ischemic Attack 21 21
Fistula 20 20
Chest Pain 20 20
Extravasation 19 19
Ruptured Aneurysm 19 19
Ischemia Stroke 18 18
Bradycardia 18 18
Arrhythmia 18 18
Ischemia 17 17
Calcium Deposits/Calcification 16 16
Infarction, Cerebral 16 16
Tachycardia 16 16
Pneumothorax 14 14
ST Segment Elevation 14 14
Reaction 14 14
Needle Stick/Puncture 14 14
High Blood Pressure/ Hypertension 14 14
Hemorrhage, Cerebral 14 14
Paralysis 13 13
Tissue Damage 12 12
Great Vessel Perforation 12 12
Dyspnea 12 12
Non specific EKG/ECG Changes 11 11
Embolus 11 11
Dysphasia 11 11
Discomfort 11 11
Ventricular Fibrillation 11 11
Heart Failure 10 10
Pulmonary Embolism 10 10
Foreign Body Embolism 10 10
Fever 9 9
Hemorrhage, Subarachnoid 9 9
Nausea 8 8
Muscle Weakness 8 8
Neurological Deficit/Dysfunction 8 8
Sepsis 8 8
Paresis 8 8
Reocclusion 7 7
Renal Failure 7 7
Visual Disturbances 7 7
Edema 7 7
Cognitive Changes 7 7
Low Oxygen Saturation 7 7
Aortic Dissection 7 7
Iatrogenic Source 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Atrial Fibrillation 6 6
Muscle Spasm(s) 6 6
Inflammation 6 6
Visual Impairment 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-07-2022
2 Arrow International Inc II Feb-14-2020
3 Arrow International Inc II Apr-10-2019
4 Arrow International Inc II Jan-11-2019
5 Arrow International Inc II Jun-29-2018
6 Arrow International Inc II May-30-2018
7 Arrow International Inc II Apr-10-2018
8 Arrow International Inc II Feb-20-2018
9 Arrow International Inc II Jun-12-2017
10 Bard Peripheral Vascular Inc II Oct-08-2020
11 Bard Peripheral Vascular Inc II May-11-2018
12 Boston Scientific Corporation II Apr-15-2021
13 Boston Scientific Corporation II Jan-15-2021
14 Boston Scientific Corporation II Nov-26-2019
15 Boston Scientific Corporation II Aug-08-2018
16 Cook Inc. II Jun-02-2020
17 Cook Inc. II Apr-25-2018
18 Cook Inc. II Mar-09-2018
19 Cook Incorporated II Jul-08-2022
20 Cordis Corporation III Apr-18-2019
21 MICROVENTION INC. III Jun-07-2021
22 Medtronic Inc I Mar-29-2018
23 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
24 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
25 Medtronic Vascular II Mar-11-2021
26 Medtronic Vascular I Oct-01-2019
27 Mivi Neuroscience Inc II Sep-09-2021
28 ReFlow Medical I Mar-29-2017
29 SPS Sterilization, Inc II Sep-13-2018
30 Stryker Neurovascular II Oct-08-2019
31 Stryker Neurovascular II Jun-02-2019
32 Stryker Neurovascular II Sep-28-2018
33 Stryker Neurovascular II Jul-28-2018
34 Vascular Solutions, Inc. I May-22-2017
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