Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered a cardiac perforation requiring pericardiocentesis.It was reported that during an idvt case, a cardiac perforation was noticed in the patient, in the posterior right ventricular outflow tract (rvot).There was a drop in blood pressure on the patient.The cardiac perforation was confirmed via intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis, and about 200cc of fluid was removed.There was a steam pop and there was also some high force readings, during the procedure.The patient is in stable condition.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
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