MAUDE manufacturer profile

BOSTON SCIENTIFIC CORPORATION · NWX

MAUDE profile for Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

Key facts

Manufacturer BOSTON SCIENTIFIC CORPORATION
Manufacturer group BOSTON SCIENTIFIC IRELAND LIMITED
Product code NWX
Product code name Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Material Rupture, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Break, Adverse Event Without Identified Device or Use Problem, Failure to Advance, Difficult to Remove, Detachment of Device or Device Component 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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