The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
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It was reported that a patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation with a decanav electrophysiology catheter and the patient experienced cardiac tamponade that required pericardiocentesis and surgical intervention.Post procedure when the patient was getting ready for discharge, the patient went into tamponade.A pericardiocentesis was performed unsuccessfully removing 1200 cc's of fluid.The patient was then taken to surgery.After treatment, the patient was in stable condition.The physician¿s opinion on the cause of this adverse event is procedure related.After placing the decanav into the coronary sinus (cs), it flipped into the ventricle.No transseptal puncture was performed.Ablation was performed prior to noting pericardial effusion.No evidence of steam pop.No error messages observed on biosense webster equipment during the procedure patient recovered and discharged home but required extended hospitalization due to surgical intervention (open sternotomy).
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