BUD DRAINAGE CATHETER

Description of Event or Problem

IT WAS REPORTED THE PATIENT UNDERWENT A PRECUTANEOUS NEPHROSTOMY FOR TREATMENT AND PLACEMENT OF THIS DRAINAGE CATHETER IN 2003, IN PREPARATION FOR URETERAL STENT PLACEMENT IN JUNE 2003. FOLLOWING PLACEMENT OF THE STENT IN JUNE 2003, IT WAS NOTED ON WITHDRAWAL OF THE DRAINAGE CATHETER THAT THE CATHETER HAD FRACTURED IN TWO PLACES. ONE SEGMENT WAS RETRIEVED. THE OTHER SEGMENT WAS NOT RETRIEVED AND REMAINED IN THE PATIENT'S KIDNEY. COMPANY'S ATTEMPTS TO OBTAIN FURTHER DETAILS HAVE BEEN UNSUCCESSFUL. SHOULD FURTHER DETAILS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. THE USER FACILITY WILL NOT RELEASE THIS DEVICE FOR EVALUATION. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. A LOT SEARCH WAS PERFORMED, AND REVEALED NO OTHER COMPLAINTS TO DATE FOR THIS LOT NUMBER. HOWEVER, WITHOUT EVALUATING THE DEVICE COMPANY IS UNABLE TO DETERMINE IF THE DEVICE MET ITS SPECIFICATIONS. USER TECHNIQUE AND/OR PATIENT CONDITION MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, COMPANY IS UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVEN.