MAUDE manufacturer profile

SILK ROAD MEDICAL · NTE

MAUDE profile for Temporary Carotid Catheter For Embolic Capture

Key facts

Manufacturer SILK ROAD MEDICAL
Manufacturer group SILK ROAD MEDICAL
Product code NTE
Product code name Temporary Carotid Catheter For Embolic Capture

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Vascular Dissection, Ischemia Stroke, Patient Problem/Medical Problem, Stroke/CVA, Brain Injury, Muscle Weakness/Atrophy, Thrombosis/Thrombus Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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