CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Description of Event or Problem

IT WAS REPORTED THAT FOLLOWING AN UNSPECIFIED ELECTROPHYSIOLOGY PROCEDURE WITH A BOSTON SCIENTIFIC DEVICE THE PATIENT EXPERIENCED AIR EMBOLISM AND STROKE. THUS, A BAT (BRAIN ATTACK TEAM) WAS CALLED, AND THE PATIENT IS BEING SEEN BY NEUROLOGY. ADDITIONAL PROCEDURE AND DEVICE DETAILS HAVE BEEN REQUESTED BUT ARE CURRENTLY UNKNOWN.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.