BARD® X-FORCE® BALLOON DILATION CATHETER

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WHO HAD A STENT PLACED AT OUR FACILITY AND WAS MANAGED AT ANOTHER FACILITY FOR APPROXIMATELY ONE YEAR PRESENTED TO OUR HOSPITAL WITH URINARY RETENTION. WHILE IT WAS POSSIBLE THAT THE STENT REMAINS INSIDE THE BODY, DETAILS CANNOT BE DETERMINED UNTIL THE URINARY RETENTION IS RESOLVED VIA A NEPHROSTOMY APPROACH. THEREFORE, THEY ARE REQUESTING INFORMATION ON WHETHER THERE HAVE BEEN ANY CASES IN THE PAST WHERE A STENT BROKE AND REMAINED INSIDE THE BODY AFTER ONE YEAR OF PLACEMENT. POSSIBILITY OF URINARY TRACT OBSTRUCTION DURING URETERAL STENT PLACEMENT.