DEVICE, CYSTOMETRIC, HYDRAULIC

Description of Event or Problem

THE EVENT INVOLVED A TDOC CATHETER, MODEL NUMBER CAT878, USED FOR A URODYNAMIC STUDY. DURING THE STUDY THE PATIENT NOTIFIED THE PROVIDER THAT THE CATHETER WAS UNCOMFORTABLE, AND THE CATHETER WAS REMOVED. THE PATIENT EXPERIENCED BLEEDING WHICH WAS CONTROLLED WITH GAUZE AND PRESSURE APPLICATION. UPON EXAMINATION OF THE CATHETER USED, THE SENSOR WIRE WITHIN THE CATHETER HAD DISLODGED FROM THE END OF THE CATHETER LIKELY CAUSING AN ABRASION OF THE URETERAL MUCOSA. THE PATIENT HAS URINARY RETENTION REQUIRING INTERMITTENT CATHERIZATION AND AN INDWELLING CATHETER HAD TO BE PLACED AT THE TIME TO AVOID FURTHER IRRITATION OF LIKELY ABRASION CAUSED BY THE CATHETER. THIS INCIDENT DID NOT RESULT IN A SERIOUS INJURY OF THE PATIENT. THE EVENT IS BEING REPORTED AS IF THIS INCIDENT WAS TO OCCUR AGAIN MAY REQUIRE MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY OF THE PATIENT.