RETROGUARD ARTERIAL SAFETY VALVE

Additional Manufacturer Narrative

VISUAL EXAMINATION OF THE DEVICE CONFIRMED THERE WAS A SIGNIFICANT CRACK IN THE HOUSING ON ONE SIDE OF THE DEVICE. IN-PROCESS INSPECTION OF THE DEVICE DURING MANUFACTURE INCLUDES A 100% LEAK TEST. IT IS UNLIKELY THE CRACK OCCURRED AT THE MANUFACTURER'S LOCATION. THIS DEVICE IS SOLD NON-STERILE TO THE DISTRIBUTOR FOR FURTHER PROCESSING (PACKAGING/STERILIZATION) PRIOR TO SHIPMENT TO CUSTOMERS. 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 MANUFACTURE FOR FURTHER PROCESSING (PACKAGING/STERILIZATION). THE REPORT STATED THAT THE ISSUE WAS FOUND AT THE HOSPITAL BY THE PERFUSIONIST WHILE PRIMING THE A-V LOOP. THE PERFUSIONIST REPORTED THAT THE RETROGUARD VALVE LEAKED, AND UPON CLOSER INSPECTION THEY FOUND A CRACK LENGTHWISE ON THE VALVE. THERE WAS NO BLOOD LOSS REPORTED BECAUSE THE ISSUE WAS FOUND DURING PRIMING (NO PATIENT INVOLVEMENT). THE DEVICE WAS RETURNED TO THE DISTRIBUTOR AND THEN TO THE MANUFACTURER FOR EVALUATION.