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 30897932l number, and no internal action 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.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).
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It was reported that a patient underwent an av node ablation procedure with two thermocool® smart touch® sf bi-directional navigation catheter¿s.The patient suffered a cardiac arrest.It was reported that the carto 3 system was displaying a force sensor error 106 when the catheter was connected to the patient interface unit (piu).The cable was replaced without resolution.The catheter was replaced and the issue was resolved.The procedure was continued.It was also reported that after the procedure was completed and while the patient was on the table, the patient coded.They reported that the patient moved his left arm up and began shaking.The patient then stopped shaking and coded.Medical intervention provided was cpr and the patient came back and had a normal sinus rhythm.The patient was being admitted.The patient was reported to be in stable condition.The patient had a medtronic device and that they were unable to find any abnormalities.The physician believed that the patient coded due to respiratory issues and not due to the procedure.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available the adverse event was assessed conservatively under both the thermocool® smart touch® sf bi-directional navigation catheter¿s used in the procedure.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.The force sensor error 106 was assessed as non mdr reportable.Warning functioned as intended.
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