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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 LTD
  SUBSTANTIALLY EQUIVALENT 1
AV MEDICAL TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 2
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR,INC(FORMERLY D.B.A EV3 INC.,COVIDIEN LLC)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC. (FORMERLY D.B.A. EV3 INC, COVIDIEN LLC.)
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 2
NEXSTEP MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ORBUSNEICH MEDICAL TRADING INC.
  SUBSTANTIALLY EQUIVALENT 1
QUALIMED USA, LLC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2081 2081
2018 2188 2188
2019 2405 2405
2020 2447 2447
2021 2501 2501

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 6390 6390
Burst Container or Vessel 1978 1978
Leak/Splash 800 800
Detachment of Device or Device Component 573 573
Difficult to Remove 568 568
Adverse Event Without Identified Device or Use Problem 435 435
Deflation Problem 411 411
Inflation Problem 344 344
Break 330 330
Material Separation 247 247
Retraction Problem 214 214
Material Deformation 181 181
Improper or Incorrect Procedure or Method 151 151
Failure to Advance 141 141
Detachment Of Device Component 134 134
Difficult to Advance 124 124
Entrapment of Device 105 105
Material Twisted/Bent 79 79
Material Puncture/Hole 75 75
Material Frayed 63 63
Peeled/Delaminated 55 55
Device-Device Incompatibility 53 53
Off-Label Use 50 50
Fluid Leak 50 50
Use of Device Problem 47 47
Device Dislodged or Dislocated 46 46
Device Handling Problem 46 46
Material Split, Cut or Torn 42 42
Material Integrity Problem 41 41
Fracture 38 38
Crack 38 38
Difficult to Insert 32 32
Packaging Problem 32 32
Kinked 26 26
Hole In Material 26 26
Device Markings/Labelling Problem 25 25
Structural Problem 24 24
Difficult To Position 24 24
Stretched 23 23
Device Damaged by Another Device 23 23
Unraveled Material 22 22
Torn Material 21 21
Device Contamination with Chemical or Other Material 21 21
Physical Resistance/Sticking 16 16
Device Damaged Prior to Use 16 16
Component Missing 15 15
Partial Blockage 15 15
Physical Resistance 14 14
Defective Device 12 12
Defective Component 12 12
Failure to Fold 12 12
Device Fell 12 12
Difficult to Open or Close 10 10
Unsealed Device Packaging 10 10
Material Fragmentation 9 9
Deformation Due to Compressive Stress 9 9
Device Operates Differently Than Expected 8 8
Insufficient Information 8 8
Decrease in Pressure 8 8
Tear, Rip or Hole in Device Packaging 8 8
Product Quality Problem 7 7
Contamination /Decontamination Problem 7 7
Difficult to Open or Remove Packaging Material 7 7
Physical Property Issue 6 6
Positioning Problem 6 6
Folded 6 6
Appropriate Term/Code Not Available 5 5
Device Expiration Issue 5 5
Bent 4 4
Occlusion Within Device 4 4
Loose or Intermittent Connection 4 4
Device Difficult to Setup or Prepare 4 4
Component Misassembled 4 4
Failure to Deflate 4 4
Device Packaging Compromised 4 4
Patient-Device Incompatibility 3 3
Pressure Problem 3 3
Migration 3 3
Delivered as Unsterile Product 3 3
Difficult to Flush 3 3
Contamination 3 3
Flaked 2 2
Degraded 2 2
Difficult or Delayed Positioning 2 2
No Display/Image 2 2
Shelf Life Exceeded 2 2
Obstruction of Flow 2 2
Device Or Device Fragments Location Unknown 2 2
Incomplete or Missing Packaging 2 2
Activation Failure 2 2
Separation Problem 2 2
Unintended Movement 2 2
Device Contaminated During Manufacture or Shipping 2 2
Expiration Date Error 2 2
Device Disinfection Or Sterilization Issue 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Separation Failure 1 1
Activation, Positioning or SeparationProblem 1 1
Aspiration Issue 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7672 7673
No Clinical Signs, Symptoms or Conditions 2339 2339
No Known Impact Or Consequence To Patient 378 378
No Patient Involvement 261 261
Stenosis 140 140
Device Embedded In Tissue or Plaque 138 138
Foreign Body In Patient 106 106
Patient Problem/Medical Problem 97 97
Insufficient Information 94 94
Vascular Dissection 92 92
No Code Available 77 77
Injury 57 57
Occlusion 57 57
Death 38 38
Thrombus 36 36
Perforation of Vessels 35 35
Hematoma 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Embolism/Embolus 27 27
Hemorrhage/Bleeding 24 24
Embolism 22 22
Thrombosis 20 20
Obstruction/Occlusion 20 20
No Information 19 19
Perforation 19 19
Reocclusion 18 18
Unspecified Tissue Injury 18 18
Restenosis 16 16
Thrombosis/Thrombus 16 16
Stroke/CVA 16 16
Intimal Dissection 16 16
Pain 14 14
Rupture 13 13
Vessel Or Plaque, Device Embedded In 13 13
Calcium Deposits/Calcification 11 11
Pseudoaneurysm 11 11
Great Vessel Perforation 10 10
Blood Loss 10 10
Needle Stick/Puncture 9 9
Unspecified Infection 9 9
Low Blood Pressure/ Hypotension 8 8
Arrhythmia 8 8
Vasoconstriction 7 7
Bradycardia 6 6
Aneurysm 6 6
Fistula 6 6
Ischemia 6 6
High Blood Pressure/ Hypertension 5 5
Extravasation 5 5
Myocardial Infarction 5 5
Not Applicable 5 5
Claudication 4 4
Thromboembolism 4 4
Pulmonary Edema 4 4
Transient Ischemic Attack 4 4
Renal Failure 4 4
Fever 4 4
Cardiac Arrest 4 4
Failure of Implant 3 3
Inflammation 3 3
Necrosis 3 3
Muscle Spasm(s) 3 3
Pneumonia 2 2
Sepsis 2 2
Tissue Damage 2 2
Cardiac Tamponade 2 2
Hemoptysis 2 2
Infarction, Cerebral 2 2
Pulmonary Embolism 2 2
Prolapse 2 2
Arteriosclerosis/ Atherosclerosis 2 2
Atrial Perforation 1 1
Cardiac Perforation 1 1
Reaction 1 1
Numbness 1 1
Coma 1 1
Diminished Pulse Pressure 1 1
Vascular System (Circulation), Impaired 1 1
Asystole 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Swelling/ Edema 1 1
Lymphoma 1 1
Hemorrhagic Stroke 1 1
Abdominal Pain 1 1
Abscess 1 1
Air Embolism 1 1
Anaphylactic Shock 1 1
Chest Pain 1 1
Cellulitis 1 1
Dyspnea 1 1
Hemorrhage, Cerebral 1 1
Hypersensitivity/Allergic reaction 1 1
Hyperthermia 1 1
Infiltration into Tissue 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Mitral Valve Stenosis 1 1
Cardiogenic Shock 1 1
Physical Entrapment 1 1
Anxiety 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 Aug-09-2021
4 Cordis Corporation II Feb-28-2020
5 Cordis Corporation II Oct-30-2019
6 Cordis Corporation II Nov-06-2018
7 Nucryo Vascular Inc. II Nov-21-2019
8 Ostial Corporation II Aug-17-2021
9 ev3 Inc. II Sep-30-2020
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