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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
CRUZAR MEDSYSTEMS INC
  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
  SUBSTANTIALLY EQUIVALENT 2
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 3
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
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 5
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 2191 2191

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3316 3316
Adverse Event Without Identified Device or Use Problem 1857 1857
Break 1661 1661
Material Deformation 1408 1408
Detachment of Device or Device Component 993 993
Leak/Splash 768 768
Physical Resistance/Sticking 735 735
Failure to Advance 601 601
Material Separation 489 489
Device Damaged Prior to Use 477 477
Kinked 442 442
Deflation Problem 437 437
Difficult to Remove 428 428
Fluid/Blood Leak 392 392
Deformation Due to Compressive Stress 383 383
Material Integrity Problem 366 366
Unraveled Material 362 362
Peeled/Delaminated 335 335
Fracture 312 312
Retraction Problem 297 297
Crack 294 294
Difficult to Advance 281 281
Detachment Of Device Component 248 248
Inflation Problem 237 237
Burst Container or Vessel 232 232
Material Frayed 229 229
Entrapment of Device 198 198
Physical Resistance 181 181
Material Split, Cut or Torn 179 179
Difficult to Insert 165 165
Mechanical Problem 140 140
Material Twisted/Bent 138 138
Device Damaged by Another Device 125 125
Out-Of-Box Failure 123 123
Material Puncture/Hole 118 118
Device Operates Differently Than Expected 113 113
Insufficient Information 95 95
Use of Device Problem 87 87
Bent 85 85
Material Fragmentation 82 82
Device Dislodged or Dislocated 81 81
Device Contamination with Chemical or Other Material 76 76
Connection Problem 76 76
Obstruction of Flow 74 74
Complete Blockage 73 73
Hole In Material 71 71
Device-Device Incompatibility 69 69
Stretched 66 66
Accessory Incompatible 55 55
Gas/Air Leak 48 48
Separation Problem 48 48
Appropriate Term/Code Not Available 47 47
Device Markings/Labelling Problem 46 46
Migration or Expulsion of Device 43 43
Improper or Incorrect Procedure or Method 42 42
Unsealed Device Packaging 41 41
Packaging Problem 38 38
Torn Material 36 36
Device Handling Problem 34 34
Biocompatibility 34 34
Defective Device 34 34
Partial Blockage 32 32
Migration 27 27
Positioning Problem 27 27
No Apparent Adverse Event 26 26
Manufacturing, Packaging or Shipping Problem 26 26
Contamination 26 26
Air Leak 25 25
Unable to Obtain Readings 25 25
Split 25 25
Component Missing 25 25
Mechanical Jam 25 25
Defective Component 24 24
Loose or Intermittent Connection 23 23
Tear, Rip or Hole in Device Packaging 22 22
Material Perforation 22 22
Device Sensing Problem 22 22
Activation, Positioning or Separation Problem 20 20
Fitting Problem 20 20
Patient Device Interaction Problem 20 20
Collapse 19 19
Sticking 17 17
Patient-Device Incompatibility 17 17
Unintended Movement 17 17
Device Contaminated During Manufacture or Shipping 16 16
Incorrect, Inadequate or Imprecise Result or Readings 15 15
Compatibility Problem 14 14
No Flow 14 14
Delivered as Unsterile Product 13 13
Difficult to Flush 13 13
Folded 12 12
Material Too Rigid or Stiff 11 11
Infusion or Flow Problem 11 11
Material Too Soft/Flexible 10 10
Device Fell 9 9
Air/Gas in Device 9 9
Dull, Blunt 9 9
Disconnection 9 9
Occlusion Within Device 9 9
Product Quality Problem 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 3978 3978
No Known Impact Or Consequence To Patient 1649 1649
No Patient Involvement 770 770
Vascular Dissection 419 419
Device Embedded In Tissue or Plaque 336 336
Foreign Body In Patient 292 292
Insufficient Information 286 286
Pericardial Effusion 231 231
No Information 205 205
Perforation of Vessels 169 169
No Code Available 168 168
Hematoma 146 146
Death 142 142
Hemorrhage/Bleeding 128 128
Cardiac Perforation 127 127
Low Blood Pressure/ Hypotension 121 121
Thrombosis/Thrombus 118 118
Perforation 113 113
Stroke/CVA 104 104
Cardiac Tamponade 102 102
Vasoconstriction 101 101
Intracranial Hemorrhage 95 95
Rupture 76 76
Vessel Or Plaque, Device Embedded In 65 65
Injury 64 64
Obstruction/Occlusion 63 63
Air Embolism 63 63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 61 61
Patient Problem/Medical Problem 57 57
Thromboembolism 54 54
Embolism/Embolus 53 53
Embolism 53 53
Pseudoaneurysm 49 49
Stenosis 48 48
Occlusion 47 47
Thrombosis 46 46
Intimal Dissection 45 45
Blood Loss 39 39
Aneurysm 38 38
Cardiac Arrest 38 38
Headache 37 37
Myocardial Infarction 36 36
Swelling/ Edema 36 36
Pain 33 33
Thrombus 31 31
Unspecified Infection 31 31
Unspecified Nervous System Problem 29 29
Ruptured Aneurysm 25 25
Chest Pain 24 24
Arrhythmia 23 23
Restenosis 23 23
Unspecified Tissue Injury 22 22
Fistula 22 22
Transient Ischemic Attack 22 22
Extravasation 20 20
Bradycardia 19 19
Ischemia 19 19
Ischemia Stroke 19 19
Tachycardia 18 18
Non specific EKG/ECG Changes 17 17
Infarction, Cerebral 16 16
Calcium Deposits/Calcification 16 16
Paralysis 15 15
Pneumothorax 14 14
ST Segment Elevation 14 14
Reaction 14 14
Hemorrhage, Cerebral 14 14
High Blood Pressure/ Hypertension 14 14
Needle Stick/Puncture 14 14
Dyspnea 13 13
Discomfort 12 12
Great Vessel Perforation 12 12
Tissue Damage 12 12
Ventricular Fibrillation 12 12
Dysphasia 11 11
Embolus 11 11
Foreign Body Embolism 11 11
Pulmonary Embolism 10 10
Fever 10 10
Heart Failure 10 10
Hemorrhage, Subarachnoid 9 9
Nausea 9 9
Sepsis 8 8
Muscle Weakness 8 8
Renal Failure 8 8
Paresis 8 8
Neurological Deficit/Dysfunction 8 8
Reocclusion 7 7
Shock 7 7
Visual Disturbances 7 7
Atrial Fibrillation 7 7
Edema 7 7
Cramp(s) /Muscle Spasm(s) 7 7
Aortic Dissection 7 7
Low Oxygen Saturation 7 7
Cognitive Changes 7 7
Iatrogenic Source 6 6
Loss of consciousness 6 6
Inflammation 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 Aug-25-2022
13 Boston Scientific Corporation II Apr-15-2021
14 Boston Scientific Corporation II Jan-15-2021
15 Boston Scientific Corporation II Nov-26-2019
16 Boston Scientific Corporation II Aug-08-2018
17 Cook Inc. II Jun-02-2020
18 Cook Inc. II Apr-25-2018
19 Cook Inc. II Mar-09-2018
20 Cook Incorporated II Jul-08-2022
21 Cordis Corporation III Apr-18-2019
22 MICROVENTION INC. III Jun-07-2021
23 Medtronic Inc I Mar-29-2018
24 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
25 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
26 Medtronic Vascular II Mar-11-2021
27 Medtronic Vascular I Oct-01-2019
28 Mivi Neuroscience Inc II Sep-09-2021
29 ReFlow Medical I Mar-29-2017
30 SPS Sterilization, Inc II Sep-13-2018
31 Stryker Neurovascular II Oct-08-2019
32 Stryker Neurovascular II Jun-02-2019
33 Stryker Neurovascular II Sep-28-2018
34 Stryker Neurovascular II Jul-28-2018
35 Vascular Solutions, Inc. I May-22-2017
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