IT WAS REPORTED THAT THE CATHETER BALLOON BURST WITHIN FORTY-EIGHT HOURS OF BEING PLACED FOLLOWING AN ABDOMINAL-PERINEAL RESECTION PROCEDURE FOR A PT WITH RECTAL CANCER. THE CATHETER HAD BEEN PLACED BEHIND THE BLADDER IN THE PERINEAL SPACE FOR USE AS A DRAIN AND TO CREATE SPACE. NO LUBRICANT WAS USED ON THE CATHETER AND IT HAD BEEN INFLATED WITH 30 CC OF SALINE. A SUTURE WAS PLACED AROUND THE CATHETER TO HOLD THE CATHETER IN POSITION AND NO TRACTION OR IRRIGATION OF THE CATHETER WAS BEING PERFORMED. THE CATHETER BALLOON WAS FOUND TO HAVE BURST WHEN THE DOCTOR ATTEMPTED TO WITHDRAW THE BALLOON INFLATION FLUID AND ONLY BLOOD WAS RETURNED. NO MEDICATION OR RADIATION HAD BEEN INSTILLED THROUGH OR IN CLOSE PROXIMITY TO THE CATHETER. NO PIECES OF THE CATHETER BALLOON WERE REPORTED MISSING AND ANOTHER CATHETER WAS NOT PLACED. THE PT IS SATISFACTORY AND NO ADD'L TREATMENT WAS REQUIRED.
N
Patient 1
NO SAMPLE OR LOT NUMBER INFO WAS PROVIDED FOR EVAL. THE DEVICE WAS USED OUTSIDE OF ITS LABELING INDICATIONS AND THE EXISTING VARIABLES THAT MAY HAVE IMPACTED THE INTEGRITY OF THE PRODUCT IS NOT KNOWN TO US. IT IS POSSIBLE THAT THE BALLOON WAS NICKED WHEN THE SUTURE WAS PLACED. THE FOLEY CATHETER IS DESIGNED FOR UROLOGICAL USE ONLY AND IS LABELED ACCORDINGLY. THE DOCTOR WAS NOTIFIED THAT THE CATHETER WAS USED OUTSIDE ITS LABELING INDICATIONS AND THAT USE OF THIS AND ANY OTHER PRODUCT IN A MANNER THAT IS NOT INDICATED ON THE PRODUCT'S LABELING MAY LEAD TO SERIOUS INJURY OR DEATH. HOWEVER LABELING CLEARLY IDENTIFIES PRODUCT FOR UROLOGICAL USE ONLY. BASELINE REPORT PREVIOUSLY FILED.