inforMED
DeathMOU

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

Model number

NA

Catalog 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