CRYOICE CRYOSPHERE CRYOABLATION PROBE

Additional Manufacturer Narrative

CASE-(B)(4) - DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. THE DEVICE WILL BE INVESTIGATED UPON RETURN. IF INVESTIGATION RESULTS INDICATE THERE WAS A PRODUCT MALFUNCTION THAT CAUSED THE REPORTED EVENT A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

ON (B)(6) 2023 A MALE PATIENT UNDERWENT A VIDEO-ASSISTED THORACOSCOPIC NUSS PROCEDURE WITH CONCOMITANT CRYO NERVE BLOCK USING A CRYOS PROBE. DURING PROCEDURE, SURGEON RELEASED THE LUNG FOLLOWING A FREEZE APPLICATION. THE CRYOS PROBE ADHERED TO LUNG TISSUE DURING REMOVAL. AS A PRECAUTION, THE SURGEON DID WEDGE RESECTION OF THE PORTION OF LUNG TISSUE THAT ADHERED TO THE PROBE, IN ORDER TO PREVENT A POSSIBLE DELAYED PNEUMOTHORAX. THERE WAS NO CONFIRMED DEVICE MALFUNCTION, AND THIS EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.