inforMED
MalfunctionMOU

GALILEO III

Received May 27, 2003 · Event occurred May 22, 2003

Report MW1028506 · MDR key 462273

Device

Generic name

Source Delivery Unit

Manufacturer

Guidant

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Difficult to Insert
  • Failure to Advance

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

AT 6 PM ON THE DAY OF EVENT, USER ADVANCED SOURCE TO ARTERY AND THE SOURCE STOPPED IN PATHWAY. THEY IMMEDIATELY PERFORMED THE EMERGENCY RESPONSE PROCEDURE ACCORDING TO THE MFR RECOMMENDATIONS IN THE USER MANUAL. THE ACTIVE SOURCE WAS RETRACTED IN THE CARTRIDGE. NO PT PROBLEM.