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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 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEGO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
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. DBA SURMODICS, INC.
  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
KOSSEL MEDTECH (SUZHOU) CO.,LTD.
  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 3
QUALIMED USA, LLC.
  SUBSTANTIALLY EQUIVALENT 1
SILK ROAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMA THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
SUMMA THERAPEUTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2405 2405
2020 2443 2443
2021 2492 2492
2022 2155 2155
2023 1806 1806
2024 1744 1744

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 8007 8007
Burst Container or Vessel 1844 1844
Difficult to Remove 720 720
Leak/Splash 713 713
Detachment of Device or Device Component 697 697
Adverse Event Without Identified Device or Use Problem 424 424
Break 411 411
Inflation Problem 336 336
Deflation Problem 336 336
Material Separation 299 299
Material Deformation 266 266
Difficult to Advance 191 191
Failure to Advance 160 160
Improper or Incorrect Procedure or Method 140 140
Entrapment of Device 131 131
Material Puncture/Hole 117 117
Material Split, Cut or Torn 107 107
Material Twisted/Bent 95 95
Retraction Problem 89 89
Device-Device Incompatibility 86 86
Material Integrity Problem 81 81
Fluid/Blood Leak 79 79
Fracture 73 73
Off-Label Use 51 51
Material Frayed 49 49
Use of Device Problem 48 48
Difficult to Insert 48 48
Stretched 46 46
Device Dislodged or Dislocated 41 41
Difficult to Open or Remove Packaging Material 34 34
Failure to Deflate 33 33
Partial Blockage 30 30
Device Handling Problem 27 27
Packaging Problem 26 26
Peeled/Delaminated 26 26
Failure to Fold 24 24
Device Contamination with Chemical or Other Material 23 23
Device Damaged Prior to Use 23 23
Device Markings/Labelling Problem 22 22
Crack 22 22
Structural Problem 22 22
Device Damaged by Another Device 20 20
Deformation Due to Compressive Stress 16 16
Physical Resistance/Sticking 16 16
Device Contaminated During Manufacture or Shipping 13 13
Defective Component 12 12
Component Missing 12 12
Unraveled Material 12 12
Mechanical Jam 11 11
Tear, Rip or Hole in Device Packaging 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7685 7685
No Consequences Or Impact To Patient 4150 4151
Insufficient Information 176 176
Foreign Body In Patient 170 170
Vascular Dissection 160 160
No Known Impact Or Consequence To Patient 141 141
No Patient Involvement 111 111
Device Embedded In Tissue or Plaque 92 92
Stenosis 81 81
Injury 54 54
No Code Available 50 50
Perforation of Vessels 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
Hematoma 47 47
Embolism/Embolus 45 45
Hemorrhage/Bleeding 44 44
Thrombosis/Thrombus 39 39
Obstruction/Occlusion 38 38
Patient Problem/Medical Problem 37 37
Restenosis 29 29
Pain 29 29
Unspecified Tissue Injury 22 22
Thrombus 20 20
Death 18 18
Perforation 18 18
Occlusion 17 17
Stroke/CVA 16 16
Embolism 14 14
Pseudoaneurysm 14 14
Thrombosis 12 12
Rupture 10 10
Reocclusion 10 10
Great Vessel Perforation 10 10
Fistula 9 9
Unspecified Infection 9 9
Myocardial Infarction 8 8
Low Blood Pressure/ Hypotension 8 8
Arrhythmia 8 8
Vasoconstriction 7 7
Swelling/ Edema 7 7
Extravasation 7 7
Calcium Deposits/Calcification 7 7
Ischemia 6 6
No Information 6 6
Blood Loss 6 6
Aneurysm 6 6
Needle Stick/Puncture 6 6
Renal Failure 5 5
Bradycardia 5 5
Intimal Dissection 5 5

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 Covidien LP II Oct-29-2024
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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