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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, anastomotic, microvascular
Regulation Description Implantable clip.
Product CodeMVR
Regulation Number 878.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 40 40
2016 22 22
2017 13 13
2018 13 13
2019 44 44
2020 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 55 55
Adverse Event Without Identified Device or Use Problem 33 33
Disconnection 17 17
Material Twisted/Bent 14 14
Detachment of Device or Device Component 7 7
Break 6 6
Fitting Problem 5 5
Activation, Positioning or SeparationProblem 5 5
Connection Problem 3 3
Device Dislodged or Dislocated 2 2
Incomplete or Inadequate Connection 2 2
Defective Component 2 2
Failure to Sense 2 2
Device Slipped 2 2
Crack 2 2
Fluid Leak 2 2
Loose or Intermittent Connection 1 1
Misconnection 1 1
Material Rupture 1 1
Entrapment of Device 1 1
Unintended Ejection 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Failure to Fire 1 1
Therapeutic or Diagnostic Output Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Difficult to Open or Close 1 1
Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 60 60
No Consequences Or Impact To Patient 42 42
Injury 16 16
No Patient Involvement 14 14
Complaint, Ill-Defined 10 10
Thrombosis 8 8
Tissue Damage 6 6
Thrombus 3 3
No Information 2 2
Device Embedded In Tissue or Plaque 1 1
Intimal Dissection 1 1
Foreign Body Sensation in Eye 1 1
Blood Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jun-30-2020
2 Baxter Healthcare Corporation II Apr-08-2020
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