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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, percutaneous
Regulation Description Percutaneous catheter.
Product CodeDQY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASAHI
  SUBSTANTIALLY EQUIVALENT 10
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  1.  K161546  R2P SlenGuide
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 3
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
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 1
CATHERA, INC.
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CRUZAR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CURATIA MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CURATIVE MEDICAL TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMDS OPERATIONS B.V.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON PROFESSIONALS, INC.
  SUBSTANTIALLY EQUIVALENT 3
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 5
NITILOOP LTD.
  SUBSTANTIALLY EQUIVALENT 4
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 3
QXMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
ROXWOOD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
SEQUENT MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
SEQUENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SILK ROAD MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (ABBOTT LABORATORIES)
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3
SUREFIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TNI MANUFACTURING, INC
  SUBSTANTIALLY EQUIVALENT 2
UPSTREAM PERIPHERAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2015 2337 2337
2016 2247 2247
2017 2486 2486
2018 2854 2854
2019 2901 2901
2020 2040 2040

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2716 2716
Break 1836 1836
Adverse Event Without Identified Device or Use Problem 1254 1254
Balloon 1246 1246
Material Deformation 1048 1048
Kinked 889 889
Detachment of Device or Device Component 816 816
Catheter 793 793
Leak/Splash 772 772
Failure to Advance 667 667
Device Damaged Prior to Use 569 569
Retraction Problem 522 522
Material Separation 480 480
Detachment Of Device Component 470 470
Shaft 467 467
Physical Resistance 431 431
Deflation Problem 415 415
Physical Resistance/Sticking 410 410
Fracture 351 351
Difficult to Remove 341 341
Unraveled Material 334 334
Burst Container or Vessel 312 312
Material Integrity Problem 301 301
Peeled/Delaminated 299 299
Crack 272 272
Difficult to Advance 234 234
Material Frayed 227 227
Entrapment of Device 226 226
Fluid Leak 211 211
Out-Of-Box Failure 206 206
Tip 199 199
Inflation Problem 191 191
Device Operates Differently Than Expected 188 188
Mechanical Problem 174 174
Difficult to Insert 149 149
Device-Device Incompatibility 124 124
Material Twisted/Bent 119 119
Device Damaged by Another Device 118 118
Hole In Material 115 115
Bent 115 115
Material Fragmentation 114 114
Accessory Incompatible 89 89
Material Split, Cut or Torn 88 88
Material Puncture/Hole 87 87
Connection Problem 87 87
Insufficient Information 83 83
Complete Blockage 72 72
Device Contamination with Chemical or Other Material 71 71
Torn Material 69 69
Device Markings/Labelling Problem 68 68
Deformation Due to Compressive Stress 67 67
Migration or Expulsion of Device 59 59
Appropriate Term/Code Not Available 56 56
Sticking 56 56
Device Dislodged or Dislocated 53 53
Use of Device Problem 53 53
Stretched 51 51
Device Handling Problem 43 43
Split 42 42
Gas Leak 41 41
Defective Device 40 40
Partial Blockage 40 40
Separation Problem 39 39
Guidewire 39 39
Unsealed Device Packaging 37 37
Air Leak 36 36
Obstruction of Flow 35 35
Product Quality Problem 35 35
Wire 33 33
Mechanical Jam 33 33
Occlusion Within Device 30 30
Hub 28 28
Improper or Incorrect Procedure or Method 26 26
Material Perforation 23 23
Melted 23 23
Packaging Problem 22 22
Device Sensing Problem 22 22
Biocompatibility 20 20
Tear, Rip or Hole in Device Packaging 20 20
Defective Component 20 20
Loose or Intermittent Connection 20 20
Positioning Problem 20 20
Component Missing 19 19
Cut In Material 19 19
Activation, Positioning or SeparationProblem 18 18
Unable to Obtain Readings 18 18
Compatibility Problem 17 17
Collapse 17 17
Human-Device Interface Problem 16 16
Migration 16 16
Delivered as Unsterile Product 16 16
Contamination 15 15
Device Operational Issue 15 15
Folded 14 14
Loss of or Failure to Bond 13 13
Disconnection 13 13
Fitting Problem 12 12
Material Distortion 12 12
Device Expiration Issue 12 12
Patient-Device Incompatibility 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8942 8942
No Known Impact Or Consequence To Patient 2577 2577
No Patient Involvement 1092 1092
Device Embedded In Tissue or Plaque 399 399
Vascular Dissection 291 291
No Information 238 238
No Code Available 208 208
Death 201 201
Foreign Body In Patient 159 159
Perforation of Vessels 138 138
Pericardial Effusion 136 136
Patient Problem/Medical Problem 98 98
Perforation 90 90
Vasoconstriction 86 86
Cardiac Perforation 83 83
Injury 77 77
Vessel Or Plaque, Device Embedded In 73 73
Intimal Dissection 71 71
Hematoma 70 70
Embolism 69 69
Rupture 68 68
Low Blood Pressure/ Hypotension 66 66
Cardiac Tamponade 60 60
Occlusion 59 59
Thrombosis 57 57
Blood Loss 48 48
Hemorrhage/Bleeding 45 45
Air Embolism 42 42
Thrombus 41 41
Headache 33 33
Aneurysm 32 32
Hemorrhage, Subarachnoid 29 29
Stenosis 29 29
Unspecified Infection 25 25
Pain 25 25
Cardiac Arrest 25 25
Stroke/CVA 25 25
Infarction, Cerebral 24 24
Pseudoaneurysm 21 21
Hemorrhage, Cerebral 21 21
No Clinical Signs, Symptoms or Conditions 21 21
Myocardial Infarction 20 20
Tissue Damage 17 17
Calcium Deposits/Calcification 17 17
Intracranial Hemorrhage 16 16
Reaction 16 16
Chest Pain 16 16
Fistula 15 15
Extravasation 15 15
Neurological Deficit/Dysfunction 14 14
Embolus 14 14
Aortic Dissection 13 13
ST Segment Elevation 12 12
Reocclusion 12 12
Heart Failure 12 12
Needle Stick/Puncture 11 11
Great Vessel Perforation 11 11
Pneumothorax 11 11
Tachycardia 11 11
Thromboembolism 10 10
Ischemia 10 10
Pulmonary Embolism 10 10
Sepsis 9 9
Foreign body, removal of 9 9
Ventricular Fibrillation 9 9
Discomfort 9 9
Edema 8 8
Fever 8 8
Muscle Spasm(s) 8 8
Dyspnea 7 7
Ventricular Tachycardia 7 7
Arrhythmia 7 7
Bradycardia 7 7
Peripheral Vascular Disease 7 7
Obstruction/Occlusion 6 6
Surgical procedure, additional 6 6
Paresis 6 6
High Blood Pressure/ Hypertension 5 5
Renal Failure 5 5
Swelling 5 5
Vascular System (Circulation), Impaired 5 5
Iatrogenic Source 5 5
Shock 5 5
Tricuspid Regurgitation 5 5
Syncope 5 5
Atrial Fibrillation 4 4
Foreign Body Reaction 4 4
Granuloma 4 4
Paralysis 4 4
Seizures 4 4
Pleural Effusion 4 4
Cardiogenic Shock 4 4
Complaint, Ill-Defined 4 4
Brain Injury 4 4
Visual Disturbances 4 4
Phototoxicity 3 3
Loss of consciousness 3 3
Inflammation 3 3
Transient Ischemic Attack 3 3
Hypovolemic Shock 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-14-2020
2 Arrow International Inc II Apr-10-2019
3 Arrow International Inc II Jan-11-2019
4 Arrow International Inc II Jun-29-2018
5 Arrow International Inc II May-30-2018
6 Arrow International Inc II Apr-10-2018
7 Arrow International Inc II Feb-20-2018
8 Arrow International Inc II Jun-12-2017
9 Bard Access Systems II Mar-13-2015
10 Bard Peripheral Vascular Inc II Oct-08-2020
11 Bard Peripheral Vascular Inc II May-11-2018
12 Bard Peripheral Vascular Inc II Apr-10-2015
13 Boston Scientific Corporation II Nov-26-2019
14 Boston Scientific Corporation II Aug-08-2018
15 Boston Scientific Corporation II Jan-05-2016
16 Boston Scientific Corporation II Jun-25-2015
17 Concentric Medical Inc II Oct-09-2015
18 Cook Inc. II Jun-02-2020
19 Cook Inc. II Apr-25-2018
20 Cook Inc. II Mar-09-2018
21 Cook Inc. II Aug-22-2016
22 Cook Inc. I Feb-24-2016
23 Cordis Corporation III Apr-18-2019
24 Medtronic Inc I Mar-29-2018
25 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Oct-01-2019
26 Medtronic Vascular II Jun-26-2015
27 Medtronic Vascular, Inc. II Nov-06-2015
28 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
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 Stryker Neurovascular II Nov-02-2016
36 Vascular Solutions, Inc. I May-22-2017
37 Vascular Solutions, Inc. I Oct-20-2016
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