FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

Description of Event or Problem

A COOK FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE WAS PLACED IN A PATIENT WITH PRE-EXISTING PURE ESOPHAGEAL ATRESIA. DURING PLACEMENT, THE GAP IMAGE INTRA- PROCEDURE MEASURED 3.8MM. MAGNETS WERE PLACED EASILY PER THE INSTRUCTIONS FOR USE. PER DAILY IMAGING, THE MAGNETS DID NOT MOVE SINCE PLACEMENT. GAP OF 3.8 WHEN MAGNETS IN PLACE DID NOT CHANGE OVER 5 DAYS, SO THE MAGNETS WERE REMOVED. THIS WAS NOT A POST-APPROVAL STUDY PATIENT. A LEAK WAS NOT IDENTIFIED. NO ADVERSE EFFECTS WERE EXPERIENCED.

Additional Manufacturer Narrative

THIS EVENT IS UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SENT.