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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
  1.  K201794  Jade
  2.  K202231  JADE
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 1544 1544

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 7894 7894
Burst Container or Vessel 2032 2032
Leak/Splash 750 750
Detachment of Device or Device Component 718 718
Difficult to Remove 690 690
Adverse Event Without Identified Device or Use Problem 448 448
Break 379 379
Inflation Problem 337 337
Deflation Problem 334 334
Material Separation 311 311
Material Deformation 243 243
Difficult to Advance 176 176
Failure to Advance 169 169
Improper or Incorrect Procedure or Method 167 167
Retraction Problem 161 161
Entrapment of Device 125 125
Material Puncture/Hole 103 103
Material Twisted/Bent 92 92
Device-Device Incompatibility 83 83
Material Split, Cut or Torn 75 75
Fluid/Blood Leak 74 74
Material Integrity Problem 69 69
Off-Label Use 60 60
Fracture 57 57
Material Frayed 53 53
Use of Device Problem 52 52
Device Dislodged or Dislocated 50 50
Difficult to Insert 48 48
Detachment Of Device Component 44 44
Peeled/Delaminated 44 44
Stretched 40 40
Device Handling Problem 38 38
Packaging Problem 32 32
Partial Blockage 28 28
Crack 27 27
Structural Problem 27 27
Device Markings/Labelling Problem 26 26
Device Damaged by Another Device 24 24
Failure to Deflate 24 24
Failure to Fold 24 24
Device Contamination with Chemical or Other Material 20 20
Difficult to Open or Remove Packaging Material 19 19
Physical Resistance/Sticking 19 19
Deformation Due to Compressive Stress 17 17
Unraveled Material 17 17
Device Damaged Prior to Use 16 16
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 8 8
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 5813 5813
No Known Impact Or Consequence To Patient 254 254
No Patient Involvement 177 177
Insufficient Information 156 156
Foreign Body In Patient 149 149
Vascular Dissection 137 137
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 41 41
Embolism/Embolus 40 40
Occlusion 37 37
Obstruction/Occlusion 31 31
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
Blood Loss 7 7
Ischemia 6 6
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
Transient Ischemic Attack 4 4
Pulmonary Edema 4 4
Necrosis 3 3
Vomiting 3 3
Failure of Implant 3 3
Extravasation 3 3
Fever 3 3
Claudication 3 3
Swelling/ Edema 3 3
Cardiac Perforation 2 2
Prolapse 2 2
Numbness 2 2
Post Operative Wound Infection 2 2
Arteriosclerosis/ Atherosclerosis 2 2
Diarrhea 2 2
Infarction, Cerebral 2 2
Pulmonary Embolism 2 2
Hypersensitivity/Allergic reaction 2 2
Hypoxia 2 2
Hemoptysis 2 2
Tissue Damage 2 2
Inflammation 2 2
Tachycardia 2 2
Nausea 2 2
Pneumonia 2 2
Sepsis 2 2
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
Anxiety 1 1
Discomfort 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
Air Embolism 1 1
Anaphylactic Shock 1 1
Bruise/Contusion 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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