CUSTOM ANGIOGRAPHIC KIT

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE ACCOUNT ALLEGES THAT DURING AN ANGIOGRAM INTERVENTION, AIR WAS INJECTED INTO THE RIGHT VENTRICL DUE TO A LEAKING MANIFOLD. NO ADDITIONAL DETAILS ARE AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. SHOULD THE DEVICE BE RETURNED TO THE MANUFACTURER AT A LATER DATE, THE INVESTIGATION WILL BE REOPENED.