It was reported that an unknown patient underwent a idvt ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring a pericardiocentesis.It was reported that the soundstar catheter was used post idvt procedure to check for an effusion.A pericardiocentesis was performed by the physician after the pericardial effusion was visualized on intracardiac echocardiography (ice).The patient was stable at the time of the call.The catheter was discarded.No other details were available at the time of the call.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.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.
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An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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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