MAUDE report

MAUDE report 38729: ROTABLATOR GUIDE WIRE

Injury · received Sep 19, 1996 · SCIMED A DIV. OF BOSTON SCIENTIFIC CORP.

Key facts

MDR report key 38729
Report number 3028919-1996-00010
Event type Injury
Brand name ROTABLATOR GUIDE WIRE
Model number TYPE C
Catalog number 22679-002
Manufacturer SCIMED A DIV. OF BOSTON SCIENTIFIC CORP.
Product code DQX
Device class Class II
Date received by FDA Sep 19, 1996
Report date Aug 20, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 10–99 Death reports for this brand
  • 100–999 Injury reports for this brand
  • Yes Adverse event flagged
  • No Product problem flagged

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

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

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