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 was performed for the finished device 31026385m number, and no internal actions related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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).
|
A patient underwent a atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a navistar¿ electrophysiology catheter and the patient suffered bradycardia and ventricular fibrillation and subsequently died.A patient with a myocardiopathy was treated by a macroentry tachicardia with general anesthesia.Ablation procedure was successful in the right atrium circuit (temperature control mode - 55ºc /50w).Tachycardia was not inducible after ablation treatment.Ablation catheter (navistar 4mm) and decapolar catheter (decanav) was removed from the patient and suddenly, the patient suffered a bradycardy and after that, a ventricular fibrillation.Several cardioversion were necessary to recover the normal heart pressure, but after many hours trying to recover the patient, she died.In physician¿s opinion, the cause of death was maybe hypoxemia during awakening of general anesthesia or any thromboembolism formation that could occlude the single coronary artery of the patient.
|