Pt underwent an electrophysiology procedure to have an ablation for artrial fibrillation.
Diagnostic catheters were inserted into the coronary sinus (cs) and the right ventricle (rv).
An acuson intracardiac echocardiographic (ice) catheter was inserted and positioned in the right atrium.
The constellation diagnostic catheter was inserted in the left atrium via a transseptal puncture using a convoy sheath.
Using ice guidance, the physician targeted the convoy sheath into the left inferior pulmonary vein (lipv), then deployed the constellation.
As evidenced on fluoroscopy, the basket distal tip of the constellation catheter appeared to be "pinched" circumferentially.
The physician removed the constellation from the targeted area of the lipv and then repositioned the sheath/constellation assembly into the left superior pulmonary vein.
At this point, the pt developed bradycardia with a heart rate of 20 bpm with no blood pressure.
Treatment of the event, believed at this time to be a vasovagal reaction, included atropine, temporary pacing, heparin reversal, and fluid administration.
Pt stabilized.
However, further assessment with the ice catheter, still positioned in the right atrium, revealed a pericardial effusion (presumably as a result of a catheter perforation) requiring a pericardialcentesis.
The pt appeared stable with a heart rate of 70 bpm and a blood pressure of 130/70mm hg.
Nonetheless, a surgical consultation was requested.
The blazer xp catheter was inserted but no ablation occurred.
Retrospectively, the perforation was believed to have resulted from the constellation deployed in the left atrial appendage rather than the targeted lipv as evidenced by the "pinched" effect on the basket distal tip.
In 06/2004, an ep technologies, inc.
Sales rep visited the facility and determined the pt had not requried surgery, was fine and released the next day.
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Device was discarded by the facility, therefore an evaluation of the actual device could not be performed.
There was no info to suggest device malfunction.
The device lot history record was reviewed with no suggestion of problems during manufacturing.
Therefore, no further device evaluation was pursued.
Perforation is a known risk of the procedure.
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