GALILEO CENTERING CATHETER III
Received Apr 16, 2004 · Event occurred Mar 17, 2004
Report 2024168-2004-00170 · MDR key 521066
Device
Generic name
Coronary Centering Catheter
Manufacturer
Guidant Vascular InterventionModel number
NACatalog number
1009492
Lot number
3090352
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Death
- Occlusion
Narrative
Description of Event or Problem
A CENTERING CATHETER WAS USED FOR A BRACHYTHERAPY PROCEDURE IN THE PROXIMAL LAD. THE PT PRESENTED TO THE CATH LAB WITH MULTIPLE CO-MORBIDITIES AND DID NOT TOLERATE ANY PART OF THE PROCEDURE WELL. PREDILATATION OF THE LESION WAS PERFORMED, AS WELL AS AN ATTEMPT TO TREAT THE LESION WITH ANOTHER CENTERING CATHETER. POSITIONING AND DELIVERY OF THERAPY WAS PERFORMED WITHOUT COMPLICATIONS WITH THE CATHETER AND THE DEVICE REMOVED. ANOTHER LESION WAS IDENTIFIED 5-10 MM PROXIMAL TO THE TREATMENT SITE AT THE LAD TAKEOFF FROM THE LEFT MAIN. IT WAS TREATED WITH A BALLOON AND A STENT. THE CIRCUMFLEX ARTERY THEN ACUTELY SHUT DOWN. MULTIPLE ATTEMPTS WERE MADE TO REOPEN THE VESSEL WITHOUT SUCCESS AND THE PT DIED. THE PHYSICIAN BELIEVED THE CENTERING CATHETER PLAYED A PART IN THE CLOSURE OF THE VESSEL.
Remedial action
- Other