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: SECTIONS 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. PER ADDITIONAL INFORMATION RECEIVED VIA RCC ON 17JUN2026 STATED THAT, THE OPTIMASTENT WAS PLACED FOLLOWING TUL FOR URINARY TRACT STONES. THE STENT WAS REMOVED THE FOLLOWING MONTH, AND NO VISIBLE DAMAGE WAS OBSERVED ON THE FIRST STENT. SUBSEQUENTLY, THE IMPLEMENTATION OF A SECOND LITHOTRIPSY PROCEDURE (TUL) TOOK PLACE. DUE TO THE PRESENCE OF MILD STENOSIS, DILATION WAS PERFORMED USING XFORCE, AND THE PROCEDURE WAS CONCLUDED BY THE PLACEMENT OF AN OPTIMA STENT. THE STENT WAS REMOVED APPROXIMATELY THREE MONTHS LATER, AND THE PATIENT WAS REFERRED TO ANOTHER FACILITY FOR FOLLOWUP. AT THAT TIME, THE REMOVED STENT UNDERWENT A ROUTINE EXAMINATION, AND THERE WAS NO INDICATION OF ANY PARTICULAR ABNORMALITIES. APPROXIMATELY 8 MONTHS LATER, THE PATIENT PRESENTED WITH URINARY RETENTION. IMAGING EVALUATION REVEALED THAT WHILE THE STRUCTURE APPEARED ONLY FAINTLY ON FLUOROSCOPY, A TUBULAR STRUCTURE MEASURING APPROXIMATELY 3 TO 4 CM WAS CLEARLY VISIBLE ON CT. THIS STRUCTURE WAS OBSERVED IN A POSITION WHERE IT PARTIALLY PROTRUDED INTO THE RENAL PELVIS IN THE VICINITY OF THE URETEROPELVIC JUNCTION (UPJ). A PERCUTANEOUS REMOVAL PROCEDURE IS SCHEDULED FOR (B)(6). A RETROGRADE APPROACH WAS DEEMED CONTRAINDICATED DUE TO THE RISK OF URETERAL INJURY DURING TRACTION. IT IS ANTICIPATED THAT ANY RESIDUAL MATERIAL WILL BE IDENTIFIED DURING THE REMOVAL, AND THE RESULTS WILL BE COMMUNICATED AT A LATER DATE. THE PATIENT HAS EXPRESSED A DESIRE TO CONFIRM WHETHER COMPENSATION WOULD BE AVAILABLE IF THE RESIDUAL MATERIAL IS DETERMINED TO BE A STENT. PER ADDITIONAL INFORMATION RECEIVED VIA RCC ON 30JUN2026, STATED THAT ON (B)(6) 2026, THE FOREIGN OBJECT WAS REMOVED VIA A PERCUTANEOUS APPROACH ANTEGRADE APPROACH THROUGH A NEPHROSTOMY. THE FOREIGN OBJECT DID NOT APPEAR TO BE A STENT; IT APPEARED TO BE A TUBULAR OBJECT APPROXIMATELY 6 CM LONG, WITH A MORTAR-LIKE SHAPE AT THE DISTAL END. IT MAY BE A COMPONENT OF THE XFORCE SYSTEM. THE CATALOG NUMBER FOR THE XFORCE SYSTEM USED AT THIS HOSPITAL IS 998404.