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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 50 50
2026 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 135 135
Adverse Event Without Identified Device or Use Problem 95 95
Positioning Failure 58 58
Positioning Problem 54 54
Break 48 48
Defective Device 31 31
Material Integrity Problem 24 24
Device-Device Incompatibility 16 16
Nonstandard Device 15 15
Difficult or Delayed Positioning 14 14
Failure to Advance 13 13
Detachment of Device or Device Component 11 11
Mechanical Problem 7 7
Difficult to Advance 7 7
Material Deformation 6 6
Contamination 3 3
Material Twisted/Bent 3 3
Mechanical Jam 3 3
Entrapment of Device 2 2
Physical Resistance/Sticking 2 2
Failure to Unfold or Unwrap 2 2
Device Contamination with Chemical or Other Material 2 2
Device Contaminated During Manufacture or Shipping 1 1
Collapse 1 1
Expiration Date Error 1 1
Difficult to Insert 1 1
Packaging Problem 1 1
Material Separation 1 1
Power Problem 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 192 192
No Consequences Or Impact To Patient 48 48
Stroke/CVA 19 19
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 10 10
Vasoconstriction 4 4
Perforation of Vessels 4 4
Transient Ischemic Attack 3 3
Obstruction/Occlusion 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Pseudoaneurysm 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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