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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temporary catheter, embolic protection, transcatheter intracardiac procedures
Definition Embolic protection for transcatheter intracardiac procedures
Product CodePUM
Regulation Number 870.1251
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 48 48
2020 73 73
2021 43 43
2022 40 40
2023 24 24
2024 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 116 116
Adverse Event Without Identified Device or Use Problem 82 82
Break 60 60
Positioning Problem 53 53
Positioning Failure 46 46
Defective Device 21 21
Material Integrity Problem 15 15
Difficult or Delayed Positioning 14 14
Failure to Advance 14 14
Detachment of Device or Device Component 12 12
Device-Device Incompatibility 9 9
Mechanical Problem 5 5
Material Twisted/Bent 4 4
Activation, Positioning or Separation Problem 3 3
Difficult to Advance 3 3
Entrapment of Device 3 3
Physical Resistance/Sticking 3 3
Material Deformation 2 2
Retraction Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Contamination 1 1
Packaging Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Damaged Prior to Use 1 1
Difficult to Flush 1 1
Gas/Air Leak 1 1
Component Missing 1 1
Perivalvular Leak 1 1
Difficult to Open or Close 1 1
Fluid/Blood Leak 1 1
Output Problem 1 1
Malposition of Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Separation 1 1
Flushing Problem 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 117 117
No Consequences Or Impact To Patient 68 68
Stroke/CVA 27 27
No Known Impact Or Consequence To Patient 22 22
Insufficient Information 10 10
Transient Ischemic Attack 4 4
Perforation of Vessels 4 4
Vasoconstriction 3 3
Hemorrhage/Bleeding 3 3
Death 2 2
Obstruction/Occlusion 2 2
Pseudoaneurysm 2 2
Aortic Insufficiency 1 1
No Code Available 1 1
Vascular Dissection 1 1
Anemia 1 1
Foreign Body In Patient 1 1
Thrombosis/Thrombus 1 1
Fever 1 1
No Patient Involvement 1 1
Hemorrhage, Cerebral 1 1
Eye Injury 1 1
Failure to Anastomose 1 1
Stenosis 1 1
Endocarditis 1 1
Thromboembolism 1 1
Low Blood Pressure/ Hypotension 1 1
Device Embedded In Tissue or Plaque 1 1
Bruise/Contusion 1 1

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