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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access
Definition Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.
Product CodePQK
Regulation Number 870.1252
Device Class 2


Premarket Reviews
ManufacturerDecision
AVENU MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AVENU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 51 51
2020 60 60
2021 74 74
2022 77 77
2023 71 71
2024 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 136 136
Material Deformation 91 91
Failure to Cut 72 72
Failure to Align 47 47
Activation Problem 36 36
Break 20 20
Device Dislodged or Dislocated 16 16
Difficult to Remove 14 14
Difficult to Advance 10 10
Device-Device Incompatibility 9 9
Activation, Positioning or Separation Problem 8 8
Device Damaged Prior to Use 7 7
Stretched 5 5
Insufficient Information 4 4
Material Twisted/Bent 4 4
Improper or Incorrect Procedure or Method 4 4
Positioning Problem 3 3
Mechanical Jam 3 3
Physical Resistance/Sticking 2 2
Detachment of Device or Device Component 2 2
Failure to Advance 2 2
Complete Loss of Power 2 2
Compatibility Problem 1 1
Mechanical Problem 1 1
Peeled/Delaminated 1 1
Device Markings/Labelling Problem 1 1
Material Puncture/Hole 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Use of Device Problem 1 1
Material Separation 1 1
No Apparent Adverse Event 1 1
Activation Failure 1 1
Migration 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 154 154
No Consequences Or Impact To Patient 90 90
Stenosis 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 47 47
Thrombosis/Thrombus 19 19
Hematoma 14 14
Insufficient Information 12 12
Obstruction/Occlusion 11 11
Swelling/ Edema 10 10
Pseudoaneurysm 9 9
Ischemia 7 7
Hemorrhage/Bleeding 6 6
Pain 5 5
Extravasation 5 5
High Blood Pressure/ Hypertension 4 4
Numbness 4 4
Unspecified Tissue Injury 4 4
Unspecified Infection 3 3
Neuropathy 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Injury 3 3
Aneurysm 3 3
Infiltration into Tissue 3 3
Cardiac Arrest 2 2
Nerve Damage 2 2
Bruise/Contusion 2 2
Restenosis 2 2
Impaired Healing 1 1
Vascular Dissection 1 1
No Information 1 1
Embolism/Embolus 1 1
Peripheral Edema 1 1
Unspecified Blood or Lymphatic problem 1 1
Uremia 1 1
Erythema 1 1
No Patient Involvement 1 1
Bradycardia 1 1
Perforation of Vessels 1 1
Fistula 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Apr-02-2020
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