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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It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac tamponade that required pericardiocentesis and surgical intervention.They were doing a cavotricuspid isthmus (cti) line at the end of the case and had a steam pop that eventually caused a tamponade and the patient had to go to the operating room (or).When they confirmed the effusion on intracardiac echocardiography (ice), they did a pericardiocentesis and it eventually escalated to a tamponade.The patient made it through surgery.However, the status of the patient is unknown.
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Additional information indicated that the physician¿s opinion on the cause of this adverse event was that it was procedure/patient condition related.The patient underwent open heart surgery to repair the resulting hole in the right atrium.Location of the perforation was right atrium by cavotricuspid isthmus (cti) line.The patient required extended hospitalization to recover from surgery.As such, the h 6.Health effect - impact code was updated and the code of hospitalization or prolonged hospitalization (f08) was added.In addition, the h 6.Health effect - clinical code of cardiac tamponade (e0605) was replaced with cardiac perforation (e0604).Relevant medical history indicated that this was the patient¿s second atrial fibrillation ablation and patient also had an existing pacemaker.Transseptal puncture was performed.No error messages observed on the biosense webster equipment during the procedure.The patient¿s age and gender were provided.Therefore, section a was updated.The physician¿s name and contact information were provided.Therefore, section e was updated.The concomitant product section was updated as additional information was received.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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