It was reported that a patient underwent an atrial fibrillation ablation with a pentaray nav high-density mapping catheter and the patient experienced pericardial effusion that required pericardiocentesis.A pericardial effusion was noticed during the procedure.The patient had a baseline effusion; however, once they had gained access to the left side, the patient's blood pressure dropped and it was confirmed with intracardiac echocardiography (ice) that the pericardial effusion had grown.Pericardiocentesis was performed.The procedure was aborted.The patient was reported to be in stable condition.No ablation had been performed.They had lost view of the transseptal wire on ice while puncturing it and that was believed to be the cause of the injury.A pentaray catheter and an smarttouch sf catheter were inside the patient's body.Additional information was received.The adverse event was discovered during use of biosense webster, inc.Products.The sheath used for transseptal puncture was the baylis versacross wire and sheath.The physician¿s opinion on the cause of the adverse event was that it was procedure related as lost sight of the transseptal needle.Patient stayed an extra night for extended monitoring.
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Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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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