RETROGUARD ARTERIAL SAFETY VALVE

Additional Manufacturer Narrative

THERE WERE NO DEVICES RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION. QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem

THE DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED BY THEIR CUSTOMER WITH THE RETROGUARD DEVICE. THIS DEVICE IS SOLD NON-STERILE TO THE DISTRIBUTOR BY THE MANUFACTURER FOR FURTHER PROCESSING. THE REPORT STATED THE DUCKBILL VALVE IN THE ARTERIAL LINE CAME OFF OF THE VALVE AND HAD TO BE ADDRESSED INTRA-OPERATIVELY. FOLLOW UP ON THE EVENT FOUND THAT THERE WAS MINIMAL AMOUNT OF PATIENT BLOOD LOST. THE REPORT STATED THE PERFUSIONIST REACTED QUICKLY AND RECONNECTED THE TUBING TO THE VALVE TO RESUME THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE CUSTOMER DID NOT KEEP THE DEVICE TO RETURN TO THE DISTRIBUTOR OR THE MANUFACTURER FOR ANALYSIS.