Description of Event or Problem · 1
ON 12/24/97 SOURCE HAD AN INCIDENT IN GERMANY WITH ONE OF CO'S PRODUCTS, CO IS WORKING WITH BFARM, FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES ON THIS INCIDENT IN ADDITION TO FILING THIS REPORT. A 60 Y/O PT WITH A PRIMARY DIAGNOSIS OF HYPOPHARYNX CARCINOMA HAD A GASTRIC FEEDING TUBE PLACED ON 12/19/97. IT WAS REPORTED THAT FIVE DAYS LATER, ON 12/24/97, THE PT. EXPERIENCED ACUTE ABDOMINAL PAIN FOLLOWED BY A SHOCK REACTION. THE PT EXPIRED ON THAT DAY. THE CAUSE OF DEATH WAS REPORTED TO BE PERITONITIS AND A PERFORATION OF THE STOMACH. THE AUTOPSY REPORT LISTED A 1 CM HOLE IN THE FRONT OF THE STOMACH. A HOLE WOULD BE EXPECTED SINCE THE PHYSICIAN PLACING THIS DEVICE WOULD MAKE A HOLE IN THE STOMACH AS A PART OF THE PLACEMENT PROCEDURE. IT HAS BEEN REPORTED THAT THE INTERNAL RETENTION DOME WAS NOT LOCATED AGAINST THE INTERNAL GASTRIC WALL, BUT WAS LOCATED AT THE ABDOMINAL WALL. THE INITIAL REPORT FROM THE PHYSICIAN INDICATED THAT HE USED A TECHNIQUE OF "TIGHT ADAPTATION" AT THE INTERNAL GASTRIC WALL TO PLACE THE DEVICE AND HIS EXPERIENCE IN PLACING PEG TUBES WAS MAINLY USING ANOTHER MFR'S NON-TRACTION REMOVABLE DEVICE. THAT NON-TRACTION REMOVABLE DEVICE MUST BE REMOVED ENDOSCOPICALLY. CO'S PRODUCT IS DESIGNED SUCH THAT WHEN IT IS TIME TO REMOVE THE DEVICE, IT MAY BE REMOVED BY TRACTION. THIS ADVANTAGEOUS ATTRIBUTE REQUIRES THAT THE PRODUCT BE USED WITH INCREASED CARE. THE FOLLOWING WARNING IS WRITTEN IN THE DIRECTIONS FOR USE: WARNING: AFTER PEG PLACEMENT, PROPER POSITIONING OF THE BUMPER AGAINST THE GASTRIC MUCOSA MUST BE ENDOSCOPICALLY VERIFIED. TENSION ON THE PED SHOULD BE AVOIDED TO MINIMIZE THE RISK OF COMPLICATIONS. FAILURE TO COMPLY WITH THE ABOVE WARNINGS MAY RESULT IN PRESSURE NECROSIS OF THE GASTRIC MUCOSA WITH SUBSEQUENT EROSION, PERFORATION, OR LEAKING OF THE GASTRIC CONTENTS INTO THE PERITONEUM. MIGRATION OF THE BUMPER INTO THE STOMA TRACT OR EMBEDDING IN THE STOMACH WALL MAY ALSO OCCUR OVER TIME. THIS PRODUCT IS NOT DESIGNED FOR "TIGHT ADAPTATION AT THE INTERNAL GASTRIC WALL." IN CONCLUSION, IT IS DIFFICULT TO ESTABLISH A DIRECT LINK OF THE INCIDENT WITH A POSSIBLE DEFECT OF THE INVOLVED MIC PULL-TYPE PEG AS OTHER FACTORS HAVE TO BE TAKEN INTO CONSIDERATION SUCH AS THE PLACEMENT TECHNIQUE, THE EXPERIENCE WITH ANOTHER PRODUCT TYPE, THE PHYSICAL CHARACTERISTICS AND THE HEALTH STATE OF THE PT.