ATRICURE CRYOICE BOX (ACM)

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE CONDUCTED AS THE LOT NUMBER FOR THE DEVICE WAS NOT REPORTED OR ABLE TO BE ASCERTAINED.

Description of Event or Problem

A PATIENT UNDERWENT MITRAL AND TRICUSPID VALVE REPAIR, WITH CONCOMITANT CRYOABLATION USING AN ACM GENERATOR. THE ACM GENERATOR WAS ATTACHED TO VACUUM ASSISTED VENOUS DRAINAGE ON THE SAME OPERATING THEATRE BOOM VIA A SUCTION DOUBLE ADAPTER DUE TO LIMITED SUCTION OUTLET SUPPLY IN THEATRE. AFTER CRYO-ABLATION COMPLETED, THE ACM DEVICE WAS VENTED PER THE NORMAL OPERATING PROCEDURE. DUE TO THE SIGNIFICANT VENTING PRESSURE, POSITIVE PRESSURE VENTED NITROUS OXIDE BACK INTO CARDIOPULMONARY BYPASS VENOUS CHAMBER AND SUBSEQUENTLY TRANSMITTED THROUGH VENOUS LINE TO PATIENT, CREATING VENOUS EMBOLISM, POSSIBLY OF NITROUS OXIDE GAS OR AIR INTO THE VENOUS SYSTEM. VENTING OF CRYOABLATION AND VACUUM ASSISTED VENOUS DRAINAGE CEASED IMMEDIATELY. SURGEON TILTED THE TABLE HEAD DOWN, FILLED THE HEART AND INCREASED CPB PRESSURE, AFTER WHICH PERFUSION CONTINUED WITHOUT FURTHER ISSUE. THERE WERE NO DETRIMENTAL EFFECTS TO THE PATIENT. PER ACM V6 IFU (P001323.G), WARNINGS, "THE ACM EXHAUST HOSE CONNECTOR REQUIRES A DEDICATED VACUUM OR WAGD PORT TO PREVENT BACK PRESSURE INTO THE PATIENT'S BREATHING LINE, WHICH MAY RESULT IN PNEUMOTHORAX." THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF POTENTIAL USE ERROR LEADING TO A PROCEDURAL COMPLICATION.