THE WOGS-1200 WAS IMPLANTED ON FRIDAY THE 08TH OF OCTOBER AND THE MEDICAL FACILITY SEND THE PT BACK TO THE OTHER HOSPITAL. THERE THE PT GOT "ILL" ON SATURDAY THE 09TH OF OCTOBER. ON SUNDAY THE 10TH, THEY MADE A EMERGENCY OPERATION BECAUSE OF PERITONITIS. ON TUESDAY THE 12TH, THE PT EXPIRED. THE CUSTOMER TOLD THE REP WHAT HAS HAPPENED WITH THE FOLLOWING INFO: DURING THE PROCEDURE, EVERYTHING WAS FINE. THEY SENT THE PT BACK TO THE OTHER HOSPITAL. IN THIS OTHER HOSPITAL THEY MANIPULATED THE CATHETER, PULLING THE CATHETER OUT OF THE BODY OF THE PT UNTIL THE FIRST SIDEHOLE WAS SEEN. THEY THEN PUSHED IT BACK INTO THE PT. THEY DID NOT KNOW THIS "NEW" PRODUCT, SO THE CUSTOMER THINKS THIS WAS A HANDLING FAILURE.
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Patient 1
PT CODE: PERITONITIS AND DEATH/EXPIRED IS NOT ADDRESSED IN THE IFU. USE OF THIS DEVICE IS PROVIDED IN THE IFU. NO PRODUCT WAS RETURNED. AN IFU IS PROVIDED, IN WHICH IT IS STATED: "DO NOT WITHDRAW THE LOOP SO FAR THAT IT BEGINS TO ENTER THE GASTROSTOMY TRACT; DOING SO MAY RESULT IN WITHDRAWAL OF CATHETER SIDEHOLES INTO THE TRACT, AND IS NOT NECESSARY FOR APPOSITION OF THE STOMACH TO THE ABDOMINAL WALL. USE FLUOROSCOPY TO FACILITATE PROPER POSITIONING OF THE CATHETER LOOP." IN THE INFO PROVIDED, THE CUSTOMER STATES, "IN THIS OTHER HOSPITAL THEY MANIPULATED THE CATHETER, SO THEY PULLED THE CATHETER OUT OF THE BODY UNTIL THE FIRST SIDE HOLE WAS SEEN, THEN THEY PUSHED IT BACK INTO THE PT." THE SIDEPORT THAT THE CUSTOMER DESCRIBES SEEING IS LOCATED WITHIN THE LOCKING LOOP. THEREFORE, IN ORDER TO VIEW THIS SIDEHOLE, THE CATHETER HAD TO HAVE BEEN IN A UNLOCKED POSITION. IT IS POSSIBLE THAT AFTER PULLING A PORTION OF THIS CATHETER OUT, THE CATHETER UNLOCKED AND WAS NOT PROPERLY REPLACED BACK INTO THE PT'S STOMACH. THIS IS LIKELY WHAT LED TO THE PT DEVELOPING PERITONITIS. WE WILL CONTINUE TO MONITOR FOR SIMILAR DEVICES AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL.