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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
ANGIOSLIDE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARRAVASC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ARRAVASC LTD
  SUBSTANTIALLY EQUIVALENT 2
AV MEDICAL TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 2
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEGO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CREAGH MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS,
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CURATIA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INFINITY ANGIOPLASTY BALLOON COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR,INC(FORMERLY D.B.A EV3 INC.,COVIDIEN LLC)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC. (FORMERLY D.B.A. EV3 INC, COVIDIEN LLC.)
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROMEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXSTEP MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ORBUSNEICH MEDICAL TRADING INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1527 1527
2017 2081 2081
2018 2188 2188
2019 2405 2405
2020 2447 2447
2021 1054 1054

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 6080 6080
Burst Container or Vessel 2118 2118
Leak/Splash 881 881
Difficult to Remove 607 607
Detachment of Device or Device Component 560 560
Deflation Problem 457 457
Adverse Event Without Identified Device or Use Problem 435 435
Inflation Problem 371 371
Break 346 346
Retraction Problem 239 239
Detachment Of Device Component 238 238
Material Separation 231 231
Material Deformation 170 170
Improper or Incorrect Procedure or Method 158 158
Failure to Advance 145 145
Entrapment of Device 121 121
Difficult to Advance 103 103
Material Twisted/Bent 70 70
Material Puncture/Hole 68 68
Material Frayed 61 61
Device Handling Problem 54 54
Peeled/Delaminated 51 51
Use of Device Problem 46 46
Fluid Leak 44 44
Crack 41 41
Physical Resistance 41 41
Device Dislodged or Dislocated 40 40
Difficult To Position 40 40
Off-Label Use 39 39
Device-Device Incompatibility 39 39
Fracture 38 38
Kinked 37 37
Hole In Material 34 34
Torn Material 34 34
Packaging Problem 32 32
Material Split, Cut or Torn 32 32
Material Integrity Problem 32 32
Difficult to Insert 30 30
Device Markings/Labelling Problem 28 28
Structural Problem 24 24
Unraveled Material 23 23
Device Damaged by Another Device 22 22
Defective Device 21 21
Device Contamination with Chemical or Other Material 21 21
Stretched 20 20
Folded 19 19
Device Damaged Prior to Use 19 19
Component Missing 17 17
Device Operates Differently Than Expected 15 15
Physical Resistance/Sticking 15 15
Partial Blockage 13 13
Defective Component 12 12
Material Fragmentation 12 12
Failure to Fold 11 11
Unsealed Device Packaging 10 10
Device Expiration Issue 10 10
Insufficient Information 9 9
Physical Property Issue 9 9
Bent 8 8
Positioning Problem 8 8
Contamination /Decontamination Problem 8 8
Deformation Due to Compressive Stress 7 7
Appropriate Term/Code Not Available 6 6
Device Fell 6 6
Tear, Rip or Hole in Device Packaging 6 6
Sticking 6 6
Product Quality Problem 6 6
Device Misassembled During Manufacturing /Shipping 5 5
Difficult to Open or Close 5 5
Difficult to Open or Remove Packaging Material 4 4
Device Packaging Compromised 4 4
Device Difficult to Setup or Prepare 4 4
Component Misassembled 4 4
Loose or Intermittent Connection 4 4
Occlusion Within Device 4 4
Delivered as Unsterile Product 3 3
Decrease in Pressure 3 3
Pressure Problem 3 3
Migration 3 3
Shelf Life Exceeded 3 3
Obstruction of Flow 3 3
Device Or Device Fragments Location Unknown 2 2
Expiration Date Error 2 2
Separation Problem 2 2
Degraded 2 2
Difficult to Flush 2 2
Unintended Movement 2 2
Activation Failure 2 2
Device Disinfection Or Sterilization Issue 2 2
Fitting Problem 2 2
Device Displays Incorrect Message 2 2
Flaked 2 2
Difficult or Delayed Positioning 2 2
Contamination 2 2
Insufficient Cooling 1 1
Component Falling 1 1
Material Discolored 1 1
Disconnection 1 1
Unintended System Motion 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8885 8886
No Clinical Signs, Symptoms or Conditions 1056 1056
No Known Impact Or Consequence To Patient 508 508
No Patient Involvement 304 304
Device Embedded In Tissue or Plaque 151 151
Stenosis 141 141
Patient Problem/Medical Problem 122 122
Foreign Body In Patient 101 101
No Code Available 80 80
Occlusion 77 77
Vascular Dissection 59 59
Injury 58 58
Insufficient Information 55 55
Death 42 42
Thrombus 37 37
Hematoma 31 31
Reocclusion 29 29
Embolism 26 26
Intimal Dissection 23 23
No Information 23 23
Hemorrhage/Bleeding 21 21
Perforation 21 21
Thrombosis 20 20
Vessel Or Plaque, Device Embedded In 20 20
Perforation of Vessels 18 18
Pain 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Calcium Deposits/Calcification 11 11
Stroke/CVA 11 11
Great Vessel Perforation 10 10
Blood Loss 10 10
Pseudoaneurysm 10 10
Rupture 10 10
Needle Stick/Puncture 9 9
Unspecified Tissue Injury 9 9
Obstruction/Occlusion 8 8
Vasoconstriction 8 8
Ischemia 8 8
Low Blood Pressure/ Hypotension 7 7
Unspecified Infection 7 7
Fistula 6 6
Bradycardia 6 6
Thrombosis/Thrombus 6 6
Claudication 5 5
Myocardial Infarction 5 5
Not Applicable 5 5
Arrhythmia 4 4
Pulmonary Edema 4 4
Embolism/Embolus 4 4
Aneurysm 4 4
Inflammation 4 4
Extravasation 4 4
Fever 4 4
Transient Ischemic Attack 4 4
Muscle Spasm(s) 3 3
Tissue Damage 3 3
Cardiac Arrest 3 3
Thromboembolism 3 3
Restenosis 2 2
Infarction, Cerebral 2 2
Hemoptysis 2 2
Peripheral Vascular Disease 2 2
Pneumonia 2 2
Cardiac Tamponade 2 2
Failure of Implant 2 2
Prolapse 2 2
Atrial Perforation 1 1
Lymphoma 1 1
Hemorrhage, Cerebral 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Hyperthermia 1 1
Dyspnea 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Air Embolism 1 1
Physical Entrapment 1 1
Coma 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Mitral Valve Stenosis 1 1
Renal Failure 1 1
Skin Irritation 1 1
Swelling 1 1
Pneumothorax 1 1
Seizures 1 1
Seroma 1 1
Tachycardia 1 1
Vomiting 1 1
Weakness 1 1
Anxiety 1 1
Discomfort 1 1
Reaction 1 1
Internal Organ Perforation 1 1
Chest Pain 1 1
Bruise/Contusion 1 1
Abdominal Pain 1 1
Anaphylactic Shock 1 1
Swelling/ Edema 1 1
Hemorrhagic Stroke 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 Medtronic Inc II Dec-22-2016
7 Nucryo Vascular Inc. II Nov-21-2019
8 Us Endovascular II Apr-11-2016
9 ev3 Inc. II Sep-30-2020
10 ev3, Inc. II Apr-22-2016
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