WI-BOX

Additional Manufacturer Narrative

THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED.

Description of Event or Problem

DURING A CMD MEASUREMENT PROCEDURE, ALL THE PRESSUERWIRES WERE PREPPED AND READY FOR CONNECTION WITH THE SYSTEM. WHEN THE SYSTEM WAS POWERED ON, THE WI-BOX LIGHT FLASHED GREEN BRIEFLY, THEN TURNED YELLOW AND NO CONNECTION COULD BE ESTABLISHED BETWEEN THE WI-BOX, PRESSUREWIRE, OR COROHUB. A SECOND ATTEMPT WAS MADE TO ESTABLISH CONNECTION, BUT THE ISSUE PERSISTED. A SECOND PRESSUREWIRE WAS OPENED AND CONNECTION WAS ATTEMPTED, BUT THE ISSUE CONTINUED. DURING TROUBLESHOOTING IT WAS DETERMINED THAT THE ISSUE WAS TRACE TO AN UNSTABLE CONNECTION OF THE WI-BOX TO THE COROHUB. ONCE THIS CONNECTIONS WAS CONFIRM, A THIRD PRESSUREWIRE WAS USED AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. DUE TO THESE ISSUES A PROCEDURE DELAY OCCURRED.