RHYTHMIA HDX MAPPING SYSTEM

Additional Manufacturer Narrative

IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT DURING A PULMONARY VEIN ABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION, A RHYTHMIA MAPPING SYSTEM - CONNECTION BOX MAESTRO WAS SELECTED FOR USE. AFTER TRANSSEPTAL PUNCTURE AND LEFT ATRIAL ACTIVATION AND VOLTAGE MAPPING, THE ABLATION CONNECTION BOX FAILED TO RECOGNIZE THE ABLATION CATHETERS AND IT WAS NECESSARY TO INTERRUPT THE PROCEDURE. IT WAS ALSO NOTED THAT THE PROCEDURE WAS STOPPED DUE TO FAILURE OF THE CATHETER. ISSUE WAS NOT ABLE TO BE RESOLVED. DUE TO THIS SERIES OF EVENTS, PROCEDURE WAS CANCELLED AND HAD TO BE RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICES ARE NOT AVAILABLE FOR RETURN.