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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
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEGO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEGO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD
  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
DK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFINITY ANGIOPLASTY BALLOON COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  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 1
NATEC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
SILK ROAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMA THERAPEUTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2188 2188
2019 2405 2405
2020 2443 2443
2021 2492 2492
2022 2154 2154
2023 1678 1678

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 7987 7987
Burst Container or Vessel 2041 2041
Leak/Splash 759 759
Detachment of Device or Device Component 720 720
Difficult to Remove 699 699
Adverse Event Without Identified Device or Use Problem 451 451
Break 385 385
Inflation Problem 340 340
Deflation Problem 337 337
Material Separation 313 313
Material Deformation 245 245
Difficult to Advance 180 180
Failure to Advance 171 171
Improper or Incorrect Procedure or Method 168 168
Retraction Problem 161 161
Entrapment of Device 126 126
Material Puncture/Hole 103 103
Material Twisted/Bent 92 92
Device-Device Incompatibility 84 84
Material Split, Cut or Torn 79 79
Fluid/Blood Leak 74 74
Material Integrity Problem 70 70
Off-Label Use 61 61
Fracture 59 59
Material Frayed 55 55
Use of Device Problem 52 52
Device Dislodged or Dislocated 51 51
Difficult to Insert 49 49
Detachment Of Device Component 44 44
Peeled/Delaminated 44 44
Stretched 41 41
Device Handling Problem 38 38
Packaging Problem 32 32
Partial Blockage 30 30
Crack 28 28
Structural Problem 27 27
Device Markings/Labelling Problem 27 27
Device Damaged by Another Device 24 24
Failure to Deflate 24 24
Failure to Fold 24 24
Difficult to Open or Remove Packaging Material 21 21
Device Contamination with Chemical or Other Material 20 20
Physical Resistance/Sticking 20 20
Deformation Due to Compressive Stress 17 17
Device Damaged Prior to Use 17 17
Unraveled Material 17 17
Component Missing 14 14
Defective Component 13 13
Hole In Material 13 13
Device Contaminated During Manufacture or Shipping 13 13
Torn Material 11 11
Difficult To Position 11 11
Unsealed Device Packaging 11 11
Mechanical Jam 10 10
Difficult to Open or Close 10 10
Component Misassembled 9 9
Decrease in Pressure 9 9
Defective Device 9 9
Material Fragmentation 9 9
Kinked 8 8
Positioning Problem 8 8
Patient-Device Incompatibility 7 7
Tear, Rip or Hole in Device Packaging 7 7
Product Quality Problem 6 6
Difficult to Flush 6 6
Accessory Incompatible 6 6
Contamination /Decontamination Problem 6 6
Insufficient Information 5 5
Appropriate Term/Code Not Available 5 5
Migration 4 4
Physical Resistance 4 4
Migration or Expulsion of Device 4 4
Device Difficult to Setup or Prepare 4 4
Suction Problem 4 4
Mechanical Problem 3 3
Obstruction of Flow 3 3
Occlusion Within Device 3 3
Flaked 3 3
Contamination 3 3
Pressure Problem 3 3
Separation Problem 3 3
Sharp Edges 2 2
Device Fell 2 2
Patient Device Interaction Problem 2 2
Physical Property Issue 2 2
Compatibility Problem 2 2
Folded 2 2
Expiration Date Error 2 2
Component or Accessory Incompatibility 2 2
No Display/Image 2 2
Degraded 2 2
Difficult or Delayed Positioning 2 2
Incomplete or Missing Packaging 2 2
Wire(s), breakage of 1 1
Device Issue 1 1
Device Or Device Fragments Location Unknown 1 1
Device Displays Incorrect Message 1 1
Malposition of Device 1 1
Reflux within Device 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5968 5969
No Clinical Signs, Symptoms or Conditions 5937 5937
No Known Impact Or Consequence To Patient 254 254
No Patient Involvement 177 177
Insufficient Information 159 159
Foreign Body In Patient 151 151
Vascular Dissection 139 139
Stenosis 127 127
Device Embedded In Tissue or Plaque 123 123
Patient Problem/Medical Problem 66 66
No Code Available 65 65
Injury 57 57
Perforation of Vessels 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 43 43
Hematoma 42 42
Hemorrhage/Bleeding 42 42
Embolism/Embolus 40 40
Occlusion 37 37
Obstruction/Occlusion 32 32
Thrombosis/Thrombus 31 31
Restenosis 28 28
Death 28 28
Thrombus 26 26
Pain 25 25
Unspecified Tissue Injury 21 21
Perforation 19 19
Stroke/CVA 16 16
Embolism 15 15
Thrombosis 15 15
Pseudoaneurysm 15 15
Reocclusion 14 14
Rupture 12 12
No Information 12 12
Great Vessel Perforation 10 10
Needle Stick/Puncture 9 9
Unspecified Infection 9 9
Low Blood Pressure/ Hypotension 8 8
Calcium Deposits/Calcification 8 8
Intimal Dissection 8 8
Arrhythmia 8 8
Myocardial Infarction 8 8
Vessel Or Plaque, Device Embedded In 7 7
Aneurysm 7 7
Fistula 7 7
Ischemia 7 7
Blood Loss 7 7
Cardiac Arrest 6 6
Bradycardia 5 5
High Blood Pressure/ Hypertension 5 5
Renal Failure 5 5
Vasoconstriction 5 5
Not Applicable 5 5
Thromboembolism 4 4
Swelling/ Edema 4 4
Transient Ischemic Attack 4 4
Pulmonary Edema 4 4
Extravasation 4 4
Fever 3 3
Failure of Implant 3 3
Necrosis 3 3
Tachycardia 3 3
Vomiting 3 3
Claudication 3 3
Cardiac Perforation 2 2
Prolapse 2 2
Numbness 2 2
Post Operative Wound Infection 2 2
Arteriosclerosis/ Atherosclerosis 2 2
Inflammation 2 2
Tissue Damage 2 2
Nausea 2 2
Pneumonia 2 2
Sepsis 2 2
Hypersensitivity/Allergic reaction 2 2
Hypoxia 2 2
Hemoptysis 2 2
Diarrhea 2 2
Infarction, Cerebral 2 2
Pulmonary Embolism 2 2
Air Embolism 1 1
Anaphylactic Shock 1 1
Bruise/Contusion 1 1
Cellulitis 1 1
Dyspnea 1 1
Hemorrhage, Cerebral 1 1
Infiltration into Tissue 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Mitral Valve Stenosis 1 1
Muscle Spasm(s) 1 1
Seroma 1 1
Skin Irritation 1 1
Swelling 1 1
Rash 1 1
Internal Organ Perforation 1 1
Pneumothorax 1 1
Neuropathy 1 1
Seizures 1 1
Ventricular Fibrillation 1 1
Physical Entrapment 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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