CRYOICE CRYOSPHERE MAX CRYOABLATION PROBE

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 A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE WITH STERNAL CRYO NERVE BLOCK THERAPY USING A CRYOSMAX DEVICE. DURING THE OPERATION, THE LEFT LUNG WAS INADVERTENTLY FROZEN BY A SURGICAL ASSISTANT. AFTER CLOSURE AND TRANSFER TO THE ICU, THE PATIENT REMAINED STABLE FOR A DAY BEFORE BEING RETURNED TO THE OR TO INVESTIGATE POSTOPERATIVE BLEEDING. A CIRCULAR INJURY WAS IDENTIFIED ON THE LEFT LUNG AND REPAIRED WITH SUTURES. DESPITE THIS, THE PATIENT DEVELOPED A PERSISTENT AIR LEAK, RESULTING IN BILATERAL LUNG COLLAPSE AND THE PLACEMENT OF PIGTAIL CATHETERS FOR DRAINAGE. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.