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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device catheter, angioplasty, peripheral, transluminal
Product CodeLIT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
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 2502 2502
2022 804 804

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 6905 6905
Burst Container or Vessel 2101 2101
Leak/Splash 836 836
Detachment of Device or Device Component 618 618
Difficult to Remove 610 610
Adverse Event Without Identified Device or Use Problem 451 451
Deflation Problem 430 430
Inflation Problem 361 361
Break 356 356
Material Separation 270 270
Retraction Problem 214 214
Material Deformation 199 199
Improper or Incorrect Procedure or Method 158 158
Failure to Advance 147 147
Difficult to Advance 139 139
Detachment Of Device Component 134 134
Entrapment of Device 115 115
Material Twisted/Bent 85 85
Material Puncture/Hole 80 80
Material Frayed 65 65
Device-Device Incompatibility 58 58
Peeled/Delaminated 55 55
Fluid Leak 54 54
Off-Label Use 53 53
Use of Device Problem 49 49
Material Integrity Problem 49 49
Device Dislodged or Dislocated 48 48
Device Handling Problem 47 47
Material Split, Cut or Torn 47 47
Crack 40 40
Fracture 39 39
Difficult to Insert 33 33
Packaging Problem 33 33
Stretched 27 27
Kinked 26 26
Hole In Material 26 26
Device Markings/Labelling Problem 25 25
Structural Problem 25 25
Device Damaged by Another Device 25 25
Difficult To Position 24 24
Unraveled Material 22 22
Device Contamination with Chemical or Other Material 22 22
Torn Material 21 21
Partial Blockage 18 18
Component Missing 17 17
Physical Resistance/Sticking 17 17
Device Damaged Prior to Use 16 16
Physical Resistance 14 14
Defective Device 12 12
Defective Component 12 12
Failure to Fold 12 12
Device Fell 12 12
Material Fragmentation 11 11
Unsealed Device Packaging 11 11
Difficult to Open or Close 10 10
Deformation Due to Compressive Stress 10 10
Device Operates Differently Than Expected 8 8
Difficult to Open or Remove Packaging Material 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
Folded 6 6
Physical Property Issue 6 6
Positioning Problem 6 6
Appropriate Term/Code Not Available 5 5
Device Expiration Issue 5 5
Bent 4 4
Loose or Intermittent Connection 4 4
Device Difficult to Setup or Prepare 4 4
Occlusion Within Device 4 4
Migration 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
Delivered as Unsterile Product 3 3
Difficult to Flush 3 3
Contamination 3 3
Flaked 3 3
Degraded 2 2
Difficult or Delayed Positioning 2 2
No Display/Image 2 2
Migration or Expulsion of Device 2 2
Mechanical Problem 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
Device Contaminated During Manufacture or Shipping 2 2
Expiration Date Error 2 2
Device Disinfection Or Sterilization Issue 2 2
Separation Problem 2 2
Sharp Edges 2 2
Activation Failure 2 2
Unintended Movement 2 2
No Apparent Adverse Event 1 1
No Pressure 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 3079 3079
No Known Impact Or Consequence To Patient 378 378
No Patient Involvement 261 261
Device Embedded In Tissue or Plaque 148 148
Stenosis 141 141
Foreign Body In Patient 115 115
Insufficient Information 113 113
Vascular Dissection 101 101
Patient Problem/Medical Problem 97 97
No Code Available 77 77
Injury 57 57
Occlusion 57 57
Death 38 38
Hematoma 37 37
Thrombus 36 36
Perforation of Vessels 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Hemorrhage/Bleeding 31 31
Embolism/Embolus 29 29
Obstruction/Occlusion 22 22
Embolism 22 22
Thrombosis 20 20
Perforation 20 20
Unspecified Tissue Injury 19 19
Restenosis 19 19
No Information 19 19
Thrombosis/Thrombus 18 18
Reocclusion 18 18
Pain 18 18
Stroke/CVA 16 16
Intimal Dissection 16 16
Rupture 14 14
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
Aneurysm 7 7
Vasoconstriction 7 7
Bradycardia 6 6
Fistula 6 6
Ischemia 6 6
High Blood Pressure/ Hypertension 5 5
Extravasation 5 5
Renal Failure 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
Fever 4 4
Cardiac Arrest 4 4
Failure of Implant 3 3
Inflammation 3 3
Vomiting 3 3
Necrosis 3 3
Muscle Spasm(s) 3 3
Nausea 2 2
Pneumonia 2 2
Sepsis 2 2
Tissue Damage 2 2
Cardiac Tamponade 2 2
Hemoptysis 2 2
Infarction, Cerebral 2 2
Diarrhea 2 2
Pulmonary Embolism 2 2
Prolapse 2 2
Swelling/ Edema 2 2
Arteriosclerosis/ Atherosclerosis 2 2
Lymphoma 1 1
Hemorrhagic Stroke 1 1
Asystole 1 1
Cramp(s) /Muscle Spasm(s) 1 1
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
Abdominal Pain 1 1
Abscess 1 1
Air Embolism 1 1
Anaphylactic Shock 1 1
Bruise/Contusion 1 1
Dyspnea 1 1
Chest Pain 1 1
Cellulitis 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

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 Covidien Llc II Feb-03-2022
8 Nucryo Vascular Inc. II Nov-21-2019
9 Ostial Corporation II Aug-17-2021
10 ev3 Inc. II Sep-30-2020
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