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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
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 2
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 1847 1847

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2674 2674
Break 1811 1811
Balloon 1245 1245
Adverse Event Without Identified Device or Use Problem 1234 1234
Material Deformation 1028 1028
Kinked 889 889
Detachment of Device or Device Component 803 803
Catheter 793 793
Leak/Splash 769 769
Failure to Advance 656 656
Device Damaged Prior to Use 564 564
Retraction Problem 522 522
Material Separation 476 476
Detachment Of Device Component 470 470
Shaft 467 467
Physical Resistance 431 431
Deflation Problem 411 411
Physical Resistance/Sticking 396 396
Fracture 349 349
Difficult to Remove 339 339
Unraveled Material 332 332
Burst Container or Vessel 305 305
Peeled/Delaminated 297 297
Material Integrity Problem 293 293
Crack 268 268
Difficult to Advance 229 229
Material Frayed 227 227
Entrapment of Device 223 223
Fluid Leak 207 207
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 148 148
Device-Device Incompatibility 124 124
Device Damaged by Another Device 117 117
Material Twisted/Bent 116 116
Hole In Material 115 115
Bent 115 115
Material Fragmentation 113 113
Accessory Incompatible 89 89
Connection Problem 87 87
Material Puncture/Hole 83 83
Material Split, Cut or Torn 83 83
Insufficient Information 81 81
Complete Blockage 72 72
Device Contamination with Chemical or Other Material 70 70
Torn Material 69 69
Device Markings/Labelling Problem 68 68
Deformation Due to Compressive Stress 62 62
Migration or Expulsion of Device 59 59
Appropriate Term/Code Not Available 56 56
Sticking 56 56
Device Dislodged or Dislocated 52 52
Use of Device Problem 52 52
Stretched 50 50
Device Handling Problem 43 43
Split 42 42
Gas Leak 41 41
Defective Device 40 40
Partial Blockage 40 40
Guidewire 39 39
Separation Problem 37 37
Air Leak 36 36
Obstruction of Flow 35 35
Unsealed Device Packaging 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 25 25
Melted 23 23
Material Perforation 23 23
Packaging Problem 22 22
Device Sensing Problem 22 22
Tear, Rip or Hole in Device Packaging 20 20
Positioning Problem 20 20
Defective Component 20 20
Loose or Intermittent Connection 20 20
Biocompatibility 19 19
Cut In Material 19 19
Collapse 17 17
Compatibility Problem 17 17
Unable to Obtain Readings 16 16
Component Missing 16 16
Human-Device Interface Problem 16 16
Activation, Positioning or SeparationProblem 16 16
Device Operational Issue 15 15
Contamination 15 15
Migration 15 15
Delivered as Unsterile Product 14 14
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 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8821 8821
No Known Impact Or Consequence To Patient 2562 2562
No Patient Involvement 1085 1085
Device Embedded In Tissue or Plaque 393 393
Vascular Dissection 284 284
No Information 238 238
No Code Available 206 206
Death 198 198
Foreign Body In Patient 155 155
Perforation of Vessels 136 136
Pericardial Effusion 133 133
Patient Problem/Medical Problem 98 98
Perforation 90 90
Vasoconstriction 85 85
Cardiac Perforation 83 83
Injury 74 74
Vessel Or Plaque, Device Embedded In 73 73
Intimal Dissection 71 71
Embolism 69 69
Hematoma 69 69
Rupture 67 67
Low Blood Pressure/ Hypotension 65 65
Cardiac Tamponade 59 59
Occlusion 58 58
Thrombosis 55 55
Blood Loss 46 46
Hemorrhage/Bleeding 45 45
Thrombus 41 41
Air Embolism 41 41
Headache 33 33
Aneurysm 32 32
Hemorrhage, Subarachnoid 29 29
Stenosis 29 29
Pain 25 25
Cardiac Arrest 25 25
Stroke/CVA 24 24
Infarction, Cerebral 24 24
Unspecified Infection 24 24
Hemorrhage, Cerebral 21 21
Pseudoaneurysm 20 20
Myocardial Infarction 19 19
Tissue Damage 17 17
Calcium Deposits/Calcification 17 17
Reaction 16 16
Fistula 15 15
Chest Pain 15 15
Intracranial Hemorrhage 15 15
Extravasation 15 15
Neurological Deficit/Dysfunction 14 14
Embolus 14 14
Aortic Dissection 13 13
ST Segment Elevation 12 12
Heart Failure 12 12
Needle Stick/Puncture 11 11
Great Vessel Perforation 11 11
Pneumothorax 11 11
Tachycardia 11 11
Reocclusion 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
Ventricular Tachycardia 7 7
Bradycardia 7 7
Peripheral Vascular Disease 7 7
Obstruction/Occlusion 6 6
Arrhythmia 6 6
Surgical procedure, additional 6 6
Paresis 6 6
Dyspnea 6 6
High Blood Pressure/ Hypertension 5 5
Renal Failure 5 5
Swelling 5 5
Vascular System (Circulation), Impaired 5 5
Syncope 5 5
Tricuspid Regurgitation 5 5
Pleural Effusion 4 4
Shock 4 4
Seizures 4 4
Cardiogenic Shock 4 4
Complaint, Ill-Defined 4 4
Brain Injury 4 4
Atrial Fibrillation 4 4
Foreign Body Reaction 4 4
Granuloma 4 4
Paralysis 4 4
Visual Disturbances 4 4
Phototoxicity 3 3
Loss of consciousness 3 3
Transient Ischemic Attack 3 3
Hypovolemic Shock 3 3
Inflammation 3 3
Complete Heart Block 3 3
Hemostasis 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 May-11-2018
11 Bard Peripheral Vascular Inc II Apr-10-2015
12 Boston Scientific Corporation II Nov-26-2019
13 Boston Scientific Corporation II Aug-08-2018
14 Boston Scientific Corporation II Jan-05-2016
15 Boston Scientific Corporation II Jun-25-2015
16 Concentric Medical Inc II Oct-09-2015
17 Cook Inc. II Jun-02-2020
18 Cook Inc. II Apr-25-2018
19 Cook Inc. II Mar-09-2018
20 Cook Inc. II Aug-22-2016
21 Cook Inc. I Feb-24-2016
22 Cordis Corporation III Apr-18-2019
23 Medtronic Inc I Mar-29-2018
24 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) I Oct-01-2019
25 Medtronic Vascular II Jun-26-2015
26 Medtronic Vascular, Inc. II Nov-06-2015
27 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
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 Stryker Neurovascular II Nov-02-2016
35 Vascular Solutions, Inc. I May-22-2017
36 Vascular Solutions, Inc. I Oct-20-2016
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