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 PRODUCT WAS RETAINED BY THE HOSPITAL PER THEIR INTERNAL POLICIES. EFFORTS ARE BEING MADE TO HAVE THE PRODUCT RETURNED OR PHOTOS PROVIDED TO ALLOW FOR AN EVALUATION OF THE DEVICE. IF PHOTOS OF THE DEVICE OR THE DEVICE ITSELF IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. 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 DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORT OF THE INCIDENT IS THE ONLY SOURCE OF INFORMATION FOR THE INVESTIGATION. BASED ON THE REPORT, THE MAGNET DETACHED AFTER THE ORAL AND GASTRIC CATHETER MAGNETS WERE SEPARATED DURING REMOVAL OF THE DEVICE AFTER SUCCESSFUL ANASTOMOSIS FORMATION. PER THE INSTRUCTIONS FOR USE "TO REMOVE MAGNET CATHETERS: ..PUSH THE ORAL CATHETER DISTALLY TOWARD THE STOMACH UNTIL MAGNETS ARE IN THE STOMACH, BELOW THE ANASTOMOSIS. THEN, GENTLY PUSH THE ORAL INNER MAGNET CATHETER AND PULL THE GASTRIC CATHETER UNTIL THE SYSTEM EXITS FROM GASTROSTOMY SITE, THUS REMOVING THE GASTROSTOMY TUBE, ORAL AND GASTRIC INNER MAGNET CATHETERS AND THE MAGNET PAIR AS A UNIT." THE MAGNETS ARE INTENDED TO BE REMOVED AS A UNIT AND NOT SEPARATED FOR REMOVAL. SEPARATION OF THE MAGNETS FOR REMOVAL CREATED THE OPPORTUNITY FOR THIS FAILURE TO OCCUR. THE SPECIFIC CAUSE OF THE MAGNET DETACHMENT CANNOT BE DETERMINED BASED ON THE CURRENT INFORMATION AVAILABLE. 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. THERE HAVE BEEN NO OTHER SIMILAR OCCURRENCES REPORTED DURING THE TIME PERIOD REVIEWED. THEREFORE, THIS REPORT REPRESENTS AN ISOLATED OCCURRENCE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

Description of Event or Problem

A PEDIATRIC PATIENT UNDERWENT PLACEMENT OF A FLOURISH DEVICE TO TREAT PRE-EXISTING ESOPHAGEAL ATRESIA. ANASTOMOSIS WAS ACHIEVED. DURING DEVICE REMOVAL, IT WAS DIFFICULT TO PASS THE WIRE GUIDE AND DIFFICULTY WAS ENCOUNTERED PUSHING THE MAGNETS OUT TOGETHER. ATTEMPTS WERE MADE TO REMOVE THE MAGNETS TOGETHER THROUGH BOTH THE MOUTH AND THE GASTROSTOMY SITE. THERE WAS MUCH MANIPULATION BY THE PHYSICIANS DURING THIS TIME. THE MAGNETS WOULD SEPARATE. THEREFORE, THE UPPER MAGNET CATHETER WAS REMOVED FROM THE MOUTH. WHEN THEY TRIED TO REMOVE THE LOWER MAGNET CATHETER FROM THE GASTROSTOMY SITE, THE MAGNET CAME LOOSE FROM THE CATHETER. THEY USED A URETERAL DILATOR TO PUSH THE MAGNET FROM THROUGH THE GASTROSTOMY SITE AND PUSH IT UP TO COME OUT OF MOUTH. THIS PATIENT IS NOT ENROLLED IN THE POST APPROVAL STUDY.