The device has been reported as discarded, 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.Manufacturer's reference number: (b)(4).
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It was reported that a male patient with a reported age of upper 60¿s underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a transient ischaemic attack (tia).The patient may have suffered a tia.This occurred after the patient had left the procedure room.Retrograde access was used to map the left ventricle, no ablation performed.Mapping was then performed in the right ventricle (rv) and right ventricular outflow tract (rvot), with ablation.The procedure was completed, and the patient was taken to post-op.The patient had undergone a computerized tomography (ct) scan after the patient could not speak (aphasia).The aphasia lasted about 30 minutes and then resolved.The ct scan showed no evidence of cerebrovascular accident (cva).The patient is currently stable and is undergoing additional testing (repeat ct scan).The patient did require hospitalization.The physician¿s opinion regarding the cause of this adverse event is that this is a potential dislodgement of plaque in the aortic root.Ablation settings: max wattage used: 30w, total lesions: approximately 6, total ablation time: 3-4 minutes & total fluid: approximately 400 ml.A transseptal puncture was not performed and there was no evidence of steam pop.Irrigation catheter flow settings were according to the instruction for use (ifu).There were no error messages observed on the biosense webster, inc.(bwi) equipment during the procedure.Force visualization features used were: dashboard, vector, visitag.The visitag module parameters for stability were: 3mm, 3 secs, and no fot.Tag index was used for color options.There was no evidence of char during the procedure and there was no evidence of blood thrombus/clot during the procedure.The correct catheter settings were selected on the generator and the pump was switching from ¿low¿ to ¿high¿ flow during ablation.
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