It was reported that the patient suffered a "right phrenic nerve disconnection".Caller stated that they connected a pentaray catheter and ablation catheter to the piu and mapped the left atrium with the pentaray catheter, ablation catheter was not inserted into the patient.A laser focus device was used on the right pulmonary veins.It was after the laser focus device was used that the "right phrenic nerve disconnection" was observed via fluoroscopy.The laser focus device was removed from the patient and the ablation catheter was inserted and the procedure was completed using rf ablation.Patient is stable at this time and the "right phrenic nerve disconnection" is not resolved.Caller was using carto 3 system 34018.Additional information was received on 04/01/2018: physician's opinion regarding the cause of the adverse event is that it was procedure-related and that it occurred while ablating with the cardiofocus heartlight laser balloon catheter.The suspected device is the cardiofocus heartlight laser balloon catheter.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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