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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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 107 107
Adverse Event Without Identified Device or Use Problem 79 79
Break 56 56
Positioning Problem 48 48
Positioning Failure 40 40
Defective Device 16 16
Failure to Advance 14 14
Difficult or Delayed Positioning 14 14
Material Integrity Problem 13 13
Detachment of Device or Device Component 11 11
Device-Device Incompatibility 8 8
Mechanical Problem 5 5
Material Twisted/Bent 4 4
Difficult to Advance 3 3
Physical Resistance/Sticking 3 3
Entrapment of Device 3 3
Activation, Positioning or Separation Problem 3 3
Retraction Problem 2 2
Material Deformation 2 2
Device Contamination with Chemical or Other Material 2 2
Gas/Air Leak 1 1
Difficult to Open or Close 1 1
Therapeutic or Diagnostic Output Failure 1 1
Output Problem 1 1
Packaging Problem 1 1
Material Separation 1 1
Device Damaged Prior to Use 1 1
Component Missing 1 1
Malposition of Device 1 1
Deformation Due to Compressive Stress 1 1
Fluid/Blood Leak 1 1
Difficult to Flush 1 1
Flushing Problem 1 1
Perivalvular Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 98 98
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
Perforation of Vessels 4 4
Transient Ischemic Attack 4 4
Vasoconstriction 3 3
Hemorrhage/Bleeding 3 3
Pseudoaneurysm 2 2
Death 2 2
Endocarditis 1 1
Eye Injury 1 1
Fever 1 1
Failure to Anastomose 1 1
Anemia 1 1
Aortic Insufficiency 1 1
Bruise/Contusion 1 1
No Patient Involvement 1 1
Thromboembolism 1 1
Foreign Body In Patient 1 1
Hemorrhage, Cerebral 1 1
Low Blood Pressure/ Hypotension 1 1
Stenosis 1 1
Obstruction/Occlusion 1 1
Vascular Dissection 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Thrombosis/Thrombus 1 1

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