MalfunctionMOU
GALILEO CENTERING CATHETER III
Received Jan 30, 2003 · Event occurred Dec 5, 2002
Report 2024168-2003-00034 · MDR key 440956
Device
Generic name
Coronary Centering Catheter
Manufacturer
Guidant Vascular InterventionModel number
NACatalog number
1009491
Lot number
2110851
Product problems
- Inflation Problem
- Leak/Splash
- Other (for use when an appropriate device code cannot be identified)
- Device, removal of (non-implant)
Patient
UNKNOWN
- No Consequences Or Impact To Patient
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE BALLOON WAS NOT INFLATING AND THERE WAS A LEAK SOMEWHERE. ATTEMPTS TO INCREASE THE PRESSURE DID NOT RESULT IN A BALLOON INFLATION. AFTER THE DEVICE WAS REMOVED FROM THE PT, FURTHER ATTEMPTS TO INFLATE THE BALLOON WERE MADE WITHOUT SUCCESS. THIS IS BEING FILED BASED ON RETURNED PRODUCT ANALYSIS, WHICH IDENTIFIED A DISTAL SHAFT INFLATION PROXIMAL TO THE BALLOON.