INTRODUCER,STD,INTRO-FLEX 9F

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, WHEN ATTEMPTING TO PERFORM "CARDIAC OUTPUT TESTS" IT WAS NOTED THAT THERE WAS "EXCESS OF FLUIDS LEAKING FROM THE SWAN" AND THE SHEATH WAS NOT LOCKED TO THE CATHETER. THE CUSTOMER REPORTED "THERE WAS A PIECE THAT WAS NOT TIGHT WITHIN THE LOCK". THE CUSTOMER REPORTED AFTER THE REPORTED INCIDENT WAS RECOGNIZED A NEW SWAN WITH A NEW SHEATH WAS PLACED WITH NO LEAKING NOTED. THE CUSTOMER REPORTED THERE WAS NO IMPACT TO THE PATIENT RELATED TO THE REPORTED INCIDENT. THE CUSTOMER REPORTED THERE IS NO SAMPLE AVAILABLE FOR RETURN EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, WHEN ATTEMPTING TO PERFORM "CARDIAC OUTPUT TESTS" IT WAS NOTED THAT THERE WAS "EXCESS OF FLUIDS LEAKING FROM THE SWAN" AND THE SHEATH WAS NOT LOCKED TO THE CATHETER.