MAUDE brand profile

JETSTREAM XC ATHERECTOMY CATHETER

MAUDE brand safety profile

Key facts

Brand name JETSTREAM XC ATHERECTOMY CATHETER

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Consequences Or Impact To Patient, Entrapment of Device, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Aspiration Issue, Mechanical Problem, Suction Problem, Embolism Most reported problems

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

About MAUDE brand safety profiles

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

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

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