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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
Regulation Description Temporary catheter for embolic protection during 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
2020 73 73
2021 43 43
2022 40 40
2023 24 24
2024 45 45
2025 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 120 120
Adverse Event Without Identified Device or Use Problem 88 88
Positioning Failure 58 58
Positioning Problem 53 53
Break 52 52
Defective Device 32 32
Material Integrity Problem 18 18
Failure to Advance 16 16
Difficult or Delayed Positioning 14 14
Device-Device Incompatibility 12 12
Detachment of Device or Device Component 11 11
Mechanical Problem 7 7
Difficult to Advance 7 7
Material Deformation 6 6
Material Twisted/Bent 5 5
Entrapment of Device 3 3
Physical Resistance/Sticking 3 3
Retraction Problem 2 2
Material Separation 2 2
Device Contamination with Chemical or Other Material 2 2
Flushing Problem 2 2
Activation, Positioning or Separation Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Malposition of Device 1 1
Output Problem 1 1
Failure to Eject 1 1
Device Damaged Prior to Use 1 1
Collapse 1 1
Difficult to Flush 1 1
Contamination 1 1
Difficult to Insert 1 1
Component Missing 1 1
Gas/Air Leak 1 1
Packaging Problem 1 1
Perivalvular Leak 1 1
Power Problem 1 1
Difficult to Open or Close 1 1
Deformation Due to Compressive Stress 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 165 165
No Consequences Or Impact To Patient 48 48
No Known Impact Or Consequence To Patient 16 16
Stroke/CVA 13 13
Insufficient Information 10 10
Vasoconstriction 4 4
Perforation of Vessels 4 4
Transient Ischemic Attack 3 3
Obstruction/Occlusion 2 2
Pseudoaneurysm 2 2
Hemorrhage/Bleeding 2 2
Aortic Insufficiency 1 1
Death 1 1
Vascular Dissection 1 1
Anemia 1 1
Fever 1 1
Foreign Body In Patient 1 1
Thrombosis/Thrombus 1 1
Hemorrhage, Cerebral 1 1
Failure to Anastomose 1 1
Eye Injury 1 1
Stenosis 1 1
Endocarditis 1 1
Thromboembolism 1 1
Low Blood Pressure/ Hypotension 1 1
Bruise/Contusion 1 1

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