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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, angioplasty, peripheral, transluminal
Regulation Description Percutaneous catheter.
Product CodeLIT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ARRAVASC LIMITED
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONTEGO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CREAGH MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 6
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NATEC MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 3
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 2
NIPRO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
O'CONNELL REGULATORY CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL COMPANY LIMITED (A COMPANY INCORPORATED IN HONG KONG)
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1277 1277
2016 1525 1525
2017 2081 2081
2018 2188 2188
2019 2405 2405
2020 2011 2011

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5623 5623
Balloon 3992 3992
Burst Container or Vessel 2074 2074
Leak/Splash 963 963
Difficult to Remove 637 637
Detachment of Device or Device Component 518 518
Deflation Problem 499 499
Adverse Event Without Identified Device or Use Problem 493 493
Inflation Problem 397 397
Catheter 388 388
Break 353 353
Detachment Of Device Component 300 300
Retraction Problem 234 234
Material Separation 205 205
Improper or Incorrect Procedure or Method 166 166
Material Deformation 159 159
Failure to Advance 148 148
Entrapment of Device 138 138
Shaft 122 122
Difficult to Advance 94 94
Material Puncture/Hole 67 67
Tip 64 64
Cutter/Blade 61 61
Material Frayed 60 60
Material Twisted/Bent 54 54
Hole In Material 53 53
Difficult To Position 51 51
Physical Resistance 51 51
Device Handling Problem 51 51
Peeled/Delaminated 51 51
Crack 49 49
Fluid Leak 47 47
Torn Material 47 47
Use of Device Problem 43 43
Kinked 40 40
Device Dislodged or Dislocated 37 37
Fracture 37 37
Defective Device 35 35
Packaging Problem 33 33
Device-Device Incompatibility 32 32
Off-Label Use 31 31
Material Split, Cut or Torn 29 29
Difficult to Insert 29 29
Device Damaged by Another Device 28 28
Folded 24 24
Device Markings/Labelling Problem 24 24
Unraveled Material 24 24
Device Damaged Prior to Use 22 22
Device Contamination with Chemical or Other Material 22 22
Material Integrity Problem 22 22
Structural Problem 22 22
Stretched 21 21
Device Operates Differently Than Expected 21 21
Component Missing 19 19
Material Fragmentation 15 15
Partial Blockage 14 14
Indicator 13 13
Sticking 13 13
Physical Resistance/Sticking 13 13
Hub 12 12
Device Expiration Issue 12 12
Insufficient Information 12 12
Unsealed Device Packaging 10 10
Bent 10 10
Failure to Fold 10 10
Physical Property Issue 9 9
Occlusion Within Device 8 8
Contamination /Decontamination Problem 8 8
Positioning Problem 8 8
Tear, Rip or Hole in Device Packaging 7 7
Device Misassembled During Manufacturing /Shipping 6 6
Product Quality Problem 6 6
Device Fell 6 6
Deformation Due to Compressive Stress 6 6
Appropriate Term/Code Not Available 6 6
Device Packaging Compromised 5 5
Difficult to Open or Close 5 5
Device Difficult to Setup or Prepare 5 5
Wire 5 5
Defective Component 5 5
Loose or Intermittent Connection 4 4
Component Misassembled 4 4
Display 4 4
Difficult to Open or Remove Packaging Material 3 3
Shelf Life Exceeded 3 3
Obstruction of Flow 3 3
Migration 3 3
Delivered as Unsterile Product 3 3
Decrease in Pressure 3 3
Contamination 3 3
Pressure Problem 3 3
Scratched Material 2 2
Unintended Movement 2 2
Activation Failure 2 2
No Pressure 2 2
Fitting Problem 2 2
Connection Problem 2 2
Device Disinfection Or Sterilization Issue 2 2
Device Displays Incorrect Message 2 2
Difficult or Delayed Positioning 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9477 9478
No Known Impact Or Consequence To Patient 604 604
No Patient Involvement 358 358
Stenosis 160 160
Device Embedded In Tissue or Plaque 150 150
Patient Problem/Medical Problem 124 124
Occlusion 106 106
Foreign Body In Patient 89 89
No Code Available 86 86
Vascular Dissection 56 56
Injury 54 54
Death 49 49
Thrombus 43 43
Embolism 37 37
No Information 36 36
Reocclusion 33 33
Intimal Dissection 31 31
Hematoma 29 29
No Clinical Signs, Symptoms or Conditions 27 27
Perforation 26 26
Thrombosis 23 23
Vessel Or Plaque, Device Embedded In 22 22
Hemorrhage/Bleeding 19 19
Perforation of Vessels 19 19
Pain 15 15
Ischemia 11 11
Blood Loss 11 11
Rupture 11 11
Pseudoaneurysm 10 10
Stroke/CVA 10 10
Calcium Deposits/Calcification 10 10
Great Vessel Perforation 10 10
Needle Stick/Puncture 9 9
Vasoconstriction 8 8
Peripheral Vascular Disease 7 7
Tissue Damage 6 6
Unspecified Infection 6 6
Fistula 5 5
Extravasation 5 5
Myocardial Infarction 5 5
Claudication 5 5
Obstruction/Occlusion 5 5
Not Applicable 5 5
Pulmonary Edema 4 4
Fever 4 4
Bradycardia 4 4
Arrhythmia 4 4
Inflammation 4 4
Low Blood Pressure/ Hypotension 4 4
Muscle Spasm(s) 3 3
Atherosclerosis 3 3
Aneurysm 3 3
Cardiac Arrest 3 3
Transient Ischemic Attack 3 3
Thromboembolism 3 3
Cardiac Tamponade 2 2
Insufficient Information 2 2
Swelling 2 2
Pneumonia 2 2
Failure of Implant 2 2
Infarction, Cerebral 2 2
Hemoptysis 2 2
Chest Pain 1 1
Hemorrhage, Cerebral 1 1
Hemorrhage, Intraventricular 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Hyperthermia 1 1
Mitral Valve Stenosis 1 1
Bruise/Contusion 1 1
Abdominal Pain 1 1
Abortion 1 1
Abscess 1 1
Air Embolism 1 1
Pneumothorax 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Internal Organ Perforation 1 1
Tachycardia 1 1
Seizures 1 1
Seroma 1 1
Skin Irritation 1 1
Weakness 1 1
Unknown (for use when the patient's condition is not known) 1 1
Foreign body, removal of 1 1
Reaction 1 1
Coma 1 1
Therapeutic Response, Decreased 1 1
Physical Entrapment 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Lymphoma 1 1
Hydrocephalus 1 1
Vascular System (Circulation), Impaired 1 1
Prolapse 1 1
Atrial Perforation 1 1
Cardiac Perforation 1 1
Diminished Pulse Pressure 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Jan-30-2020
2 BrosMed Medical Co.,Ltd. II Feb-27-2019
3 Cordis Corporation II Feb-28-2020
4 Cordis Corporation II Oct-30-2019
5 Cordis Corporation II Nov-06-2018
6 Cordis Corporation II Jan-16-2015
7 EXP Pharmaceutical Services Corp II Jul-24-2015
8 Medtronic Inc II Dec-22-2016
9 Nucryo Vascular Inc. II Nov-21-2019
10 Us Endovascular II Apr-11-2016
11 ev3 Inc. II Sep-30-2020
12 ev3, Inc. II Apr-22-2016
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