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 (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and developed neurological deficiencies requiring no interventions.During the procedure, no biosense webster inc.(bwi) product malfunctions nor immediate consequences occurred.No visible damages or residue on the catheter were observed.Post-procedure, during monitoring, the patient showed neurological deficiencies that lasted for a couple of hours and went away after a while (same day).The patient back to normal without any therapeutic intervention applied.Prolonged hospitalization was not required.The customer did not experience any issues during the procedure.Nothing special happened during the procedure.It is the physician¿s opinion that the issues must have been caused by a thermocool® smart touch® sf bi-directional navigation catheter (stsf) malfunction.Although no issues were perceived during or after the procedure.Dashboard and vector were used as force visualization features.The event was initially assessed as a non-mdr reportable, patient event non-serious, neurological complication since no intervention nor prolonged hospitalization was required to prevent permanent impairment of a body function or permanent damage of a body structure, however, on 2/4/2021 an internal review of the event was assessed by bwi¿s medical safety officer who reassessed the event as a transient ischemic attack and mdr reportable as a serious injury.
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