E1 initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31066140l number, and no internal action related to the complaint was found during the review.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 reference number: (b)(4).
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It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and when the patient was extubated after afl procedure, it was found that thrombus adhered to inquiry catheter (sjm) which was used as halo.The thrombus was on the tip of the electrode.There were no error messages or issues related to temperature and flow on the catheter.Power control mode.Temperature cut off: 40, impedance cut off:250o.Impedance: 400o, power: 35w.The bw catheter used in the procedure was smart touch sf catheter only.No further action was taken because the procedure was completed.The patient did not exhibit any neurological symptoms.No patient consequences were reported.The thrombus is mdr-reportable.
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