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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, catheter or guidewire, steerable (magnetic)
Product CodeNDQ
Regulation Number 870.1290
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 4 4
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Self-Activation or Keying 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Noise, Audible 1 1
Unexpected Shutdown 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Smoking 1 1
Use of Device Problem 1 1
Fire 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Vascular Dissection 1 1
No Code Available 1 1
Heart Block 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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