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 heart block.First, it was reported that one spline of the octaray was not displayed and there was noise overall on the octaray potential on carto3.Noise occurred.Intracardiac only, in both carto3 and lab, the catheter was in the patient¿s body at the time of the noise.Noise occurred throughout the entire octaray potentials.Cable was replaced but no improvement.The physician decided to continue the procedure.Noise improved over time, but did not disappear completely.It was also reported that av block occurred when cti was ablated.The ablation was stopped immediately after confirming the av block, but it remained blocked until the patient left the room.Additional information was received.Outcome of the adverse event is unchanged.The spline not displayed and noise issues were assessed as non mdr reportable.The adverse event was assessed as mdr reportable.
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E1.Initial reporter phone: (b)(6).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.A manufacturing record evaluation was performed for the finished device number lot 31233058l and no internal actions related to the complaint was found during the review.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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